Global Medical Device Podcast Powered By Greenlight Guru podcast

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36:27

Not many artists actually hail from Tennessee, but the scenic valleys and rolling hills of The Volunteer State are part of Dustin Lynch’s DNA. In this episode of On the Bus, Country Thunder CEO Troy Vollhoffer sits down with Dustin to discuss his journey from playing fraternity parties and weddings across the southeast to being the first country artist with a club residency at the Wynn in Las Vegas. Plus, stick around for our new segment, Thunder Strike, where Troy features upcoming festival performer Riley Green’s hit song “Damn Good Day to Leave” to give you a taste of what’s to come at Country Thunder in 2025.…

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The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Global Medical Device Podcast powered by Greenlight Guru

1
#399: How To Approach Culture Differences 22:41

πριν 7 weeks22:41

22:41

In this episode of the Global Medical Device Podcast , host Etienne Nichols sits down with Olga Chashchina, a MedTech startup founder with extensive international experience. They explore how cultural differences affect communication in the medical device industry and the importance of understanding intercultural nuances. Drawing from the book The Culture Map by Erin Meyer, Olga shares practical insights on managing global teams, the role of context in communication styles, and how cultural awareness can improve both workplace dynamics and patient care. Key Timestamps: 00:00 – Intro & Sponsor: Introduction to the episode and Greenlight Guru sponsorship 02:20 – Meet Olga Chashchina: Olga’s background in MedTech and international work experience 06:45 – Understanding Cultural Missteps: Common mistakes when navigating cultural differences in teams 12:15 – High vs. Low Context Communication: How context affects communication styles across cultures 15:00 – Cultural Impact on Healthcare: How cultural backgrounds influence patient care and medical communication 18:30 – Feedback Across Cultures: Differences in giving and receiving feedback globally 20:00 – Building Personal Connections in Professional Settings: Balancing personal relationships and cultural norms in business 22:00 – Final Thoughts: Olga’s key takeaway for appreciating cultural diversity Quotes: "The biggest problem in intercultural management is thinking everybody thinks the same way." – Olga Chashchina \ "Positive feedback should be well-measured and well-argued; a vague 'amazing' doesn’t help anyone improve." – Etienne Nichols "Sometimes you need the culture map in the beginning, but eventually, you just see the person in front of you." – Olga Chashchina Takeaways: Key Insights on MedTech Trends: Global Teams Need Cultural Awareness: Effective communication hinges on understanding cultural contexts. Healthcare is Deeply Cultural: Patient care varies across cultures due to differences in symptom expression and medical expectations. Feedback Styles Differ Greatly: Recognizing how cultures approach feedback can prevent misunderstandings and improve collaboration. Practical Tips for MedTech Professionals: Educate Yourself: Read books like The Culture Map to understand global communication styles. Ask, Don’t Assume: Always ask clarifying questions rather than assuming shared context. Balance Praise and Constructive Feedback: Be specific and culturally sensitive when providing feedback. Future-Focused Questions: How will global team dynamics evolve with remote work becoming the norm? Can AI tools help bridge cultural communication gaps in healthcare? What future training will be essential for MedTech leaders to manage diverse teams effectively? References: The Culture Map by Erin Meyer – A pivotal resource discussed in the episode for understanding intercultural communication. Etienne Nichols’ LinkedIn – Connect with Etienne for more insights and MedTech discussions. Olga Chaschina's LinkedIn - connect with Olga for more information about the work she is doing with Metyos . MedTech 101 – Beginner’s Section: Key Terms: High-Context Communication: Communication where much of the information is implied or derived from context (e.g., Russia, Japan). Low-Context Communication: Direct communication with explicit details (e.g., USA, Germany). Intercultural Management: Strategies to effectively manage teams from diverse cultural backgrounds. Questions for the Audience: Poll: How much does cultural awareness influence team success in MedTech? Very Much Somewhat Not Much Not at All 👉 Share your thoughts! Email us at podcast@greenlight.guru Discussion Question: What cultural differences have you experienced in healthcare or MedTech? How did you navigate them? Share with us via email! Feedback & Call to Action: Enjoyed this episode? Please leave us a review on iTunes! It helps others find us and improve future content. Send your feedback or topic suggestions to podcast@greenlight.guru Sponsors: This episode is sponsored by Greenlight Guru – the leading QMS software built exclusively for the MedTech industry. Stay compliant, accelerate innovation, and simplify your product lifecycle. Learn more at www.greenlight.guru .…

Global Medical Device Podcast powered by Greenlight Guru

1
#398: Game-Changing Connections in MedTech: Inside LSI with Scott Pantel 35:52

πριν 8 weeks35:52

35:52

In this episode of the Global Medical Device Podcast , host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization. Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful relationships within the medtech ecosystem. Learn how LSI’s global meetings—from Dana Point to Portugal, London, and Singapore—create spaces where deals happen, ideas flourish, and the future of patient care is shaped. Plus, Scott offers actionable advice for medtech founders preparing for investor pitches and shares inspiring stories of industry impact. Key Timestamps [02:10] – LSI’s partnership with Greenlight Guru and the value of ecosystem collaboration [05:30] – Scott Pantel’s journey into medtech and how LSI was born [12:20] – Reinventing the investor meeting experience: “There’s got to be a better way” [18:45] – The power of unexpected connections: Coffee chats, cab rides, and transformative deals [25:10] – Heartfelt story: How an Edwards Lifesciences valve saved Scott’s aunt’s life [31:00] – The role of fun and social events in serious deal-making (yes, golf included!) [39:20] – Global expansion: Why LSI is heading to Singapore in 2025 [45:50] – What makes a medtech pitch stand out to investors [53:15] – The importance of patient-centered innovation and next-gen leadership [59:00] – 🎉 Exclusive! Etienne is joining LSI’s “Game Day” commentary stage at Dana Point Quotes to Remember "Some of the most valuable connections are the ones you never planned for—like meeting someone at the coffee stand or sharing a cab ride to the airport." – Scott Pantel "Investors hear pitches all the time. Tell them how you’re going to make money—clear, concise, compelling." – Scott Pantel "There’s never been a more exciting time to be in medtech. The convergence of AI, wearables, and patient-driven care is revolutionizing healthcare." – Etienne Nichols "Relationships aren’t just nice to have; they’re how deals get done in this industry." – Scott Pantel Top MedTech Insights Relationships Drive Results : Successful deals often stem from unplanned, personal interactions beyond formal meetings. Global Expansion is Essential : Medtech innovators can’t ignore APAC markets—capital and patient demand in Asia are reshaping the industry. 3 Practical Tips for MedTech Innovators Prepare Beyond the Pitch : Articulate how your company makes money early in conversations with investors. Prioritize Presence : Spend time at networking events—connections happen when you least expect them. Know the Culture : Adapt your approach to different markets; relationship-building is key in Europe and APAC. References & Resources Learn more about LSI: Life Science Intelligence Connect with Etienne Nichols: LinkedIn Profile Explore Greenlight Guru’s solutions: Greenlight Guru MedTech 101: What’s LSI? LSI (Life Science Intelligence) hosts premier global events connecting medtech innovators with investors, helping startups scale from idea to commercialization. With flagship events in the U.S., Europe, and now Asia, LSI creates unmatched opportunities for deal-making and knowledge-sharing. Audience Poll & Discussion Poll: What MedTech trend excites you the most? 🔲 AI in diagnostics 🔲 Wearable health monitors 🔲 Surgical robotics 🔲 Patient-owned health data 👉 Email your answer to podcast@greenlight.guru ! We Want Your Feedback! Love this episode? Got suggestions for future topics? Drop us a line at podcast@greenlight.guru . 💬 Leave a review on iTunes! It helps others find the show and keeps us improving. Sponsor Spotlight This episode is brought to you by Greenlight Guru —the only MedTech-specific Quality Management Software that helps companies get products to market faster and with less risk. Ready to streamline your compliance? Visit Greenlight Guru today! 🔥 Don’t miss Etienne’s live commentary at LSI Dana Point’s “Game Day” stage! See you in March!…

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1
#397: Winning Over Skeptics: the Key to Product Adoption in Healthcare 33:12

πριν 9 weeks33:12

33:12

In this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her patient advocacy. The conversation dives deep into why healthcare professionals are skeptical of new devices, how authenticity and storytelling improve adoption, and what MedTech professionals often overlook when pitching to clinicians. Tiffany also reveals the importance of grassroots movements within medical communities, why workflow integration matters more than flashy features, and how patient education should never be an afterthought. Key Timestamps: 00:00 – Introduction & Sponsor Message (Greenlight Guru) 02:15 – Tiffany Ryder’s unique career path and patient advocacy roots 10:30 – Turning skepticism into belief: What clinicians really want to hear 18:45 – Personal experience shaping patient communication and device adoption 25:00 – Case study: Why a vein finder device sits unused in the hospital closet 34:15 – The importance of workflow integration for successful product adoption 41:50 – Grassroots influence: How clinicians share device recommendations 47:20 – Tiffany’s “what’s in your emergency room backpack” essentials 53:00 – Final advice: Talk to your biggest skeptics, not just early adopters 58:15 – Importance of patient education in medical device usage Memorable Quotes: “Authenticity comes through. You can’t sell snake oil to a clinician who’s sacrificed years of their life to help patients.” – Tiffany Ryder “If your device saves me time or helps my patients, I’ll listen. Otherwise, it’s just another thing in the closet.” – Tiffany Ryder “Find your harshest critic, not your biggest fan. That’s where real product improvement happens.” – Tiffany Ryder Key Takeaways: 🔍 MedTech Trends: Grassroots Advocacy: Clinician word-of-mouth remains a powerful tool in product adoption. Workflow Integration: Devices must improve efficiency without adding complexity. Patient-Centric Design: Products that consider patient education and usability stand out. 🛠️ Practical Tips: Engage Skeptics Early: Prioritize conversations with clinicians who question your device. Tell Compelling Stories: Use real-life patient and clinician testimonials to foster connection. Show Workflow Benefits: Highlight how your product saves time or improves patient outcomes. References: Visit Greenlight Guru for quality management solutions tailored for MedTech. Connect with Etienne Nichols on LinkedIn to share your feedback or ideas. Connect with Tiffany Ryder on LinkedIn Learn more about Red Flag Hero , Tiffany Ryder’s patient advocacy initiative. MedTech 101: Beginner’s Section Product Adoption: The process by which healthcare professionals begin using a new device regularly. Success depends on clinical evidence, ease of use, and workflow integration. Workflow Integration: Ensuring a device fits into a clinician’s existing routine without disrupting patient care. Grassroots Movement: Adoption driven by peers, not just sales teams—often more effective in healthcare environments. Audience Questions & Poll: Poll: What’s the biggest factor influencing your adoption of new medical technology? Clinical evidence Workflow integration Patient outcomes Cost savings 👉 Cast your vote and tell us why at podcast@greenlight.guru ! Discussion Question: What device has made the biggest difference in your clinical or patient care experience? Share your story with us! Feedback & Reviews: Enjoyed the episode? Leave us a ⭐⭐⭐⭐⭐ review on iTunes! Your feedback shapes future topics—email us at podcast@greenlight.guru with suggestions! Sponsor Spotlight: Greenlight Guru – Purpose-built QMS software designed to help MedTech companies ensure compliance, reduce risk, and get to market faster. Visit Greenlight Guru to learn how they can transform your quality management approach. Thank you for tuning in to the Global Medical Device Podcast—your trusted source for MedTech insights! 🎙️…

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#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions 50:33

πριν 16 weeks50:33

50:33

In this episode of the Global Medical Device Podcast , Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators. Key Timestamps [00:01] Introduction: Why device descriptions are foundational for regulatory submissions. [07:15] Common challenges: Why device descriptions are often poorly written. [14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways. [25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences. [36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA. [50:30] Final recommendations: Testing the efficacy of your device description. Memorable Quotes Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively." Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection." Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly." Key Takeaways MedTech Trends Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification. Visual aids, like images and videos, are becoming standard tools to enhance submissions. Practical Tips Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists. Incorporate visuals or videos to clarify complex mechanisms or testing processes. Future Questions How might advancements in AI reshape the expectations for device descriptions? Could the FDA eventually require interactive or multimedia submissions as standard? What new tools or technologies can help manufacturers streamline the description-writing process? References & Resources Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more . Stephen Covey: Seven Habits of Highly Effective People —inspiration for improving communication practices. Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now . MedTech 101: Device Descriptions What is a device description? A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes: Anatomy: Components and materials. Physiology: Function and mechanism of action (MOA). Pathology: Risks or potential failures. Why it matters: Guides regulatory classification and testing requirements. Establishes a clear understanding for reviewers, ensuring smooth approval processes. Audience Poll & Call to Action Poll Question: What challenges have you faced in creating a device description? Ambiguity in regulatory expectations Balancing technical detail with simplicity Miscommunication with reviewers Other (email us at podcast@greenlight.guru ) Feedback & Sponsors We value your feedback! Leave a review on iTunes to help others discover the podcast. Send suggestions for future episodes to podcast@greenlight.guru . Sponsor: This episode is brought to you by Greenlight Guru , the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.…

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1
#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond 42:04

πριν 17 weeks42:04

42:04

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future. Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices. Key Timestamps [02:30] – Introducing Leo Eisner and his expertise in IEC 60601 and global standards. [06:45] – The complexities of updating IEC 60601 and its 12 working groups. [12:20] – Expected timeline for the fourth edition (2029-2030) and why companies need to plan now. [18:50] – Overview of the most significant upcoming changes, including wireless coexistence and integration of collateral standards. [27:00] – Practical advice for navigating new standards during product development. [36:15] – How to engage in the standards development process and submit comments. [48:30] – Benefits of proactive planning and test preparation for regulatory success. [53:45] – The importance of staying informed and embracing continuous learning in MedTech. Top Quotes from the Episode "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner "IEC 60601 is often thought of as just an electrical standard, but it’s so much more—it’s about mitigating risks across all aspects of a device." – Leo Eisner "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols Key Takeaways Latest Trends in MedTech Standards The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations. Wireless coexistence and other cutting-edge technologies will soon become international requirements. Consolidating collateral standards improves consistency and reduces redundancies. Practical Tips for Compliance Begin designing for new standards early, even before they are finalized. Stay informed by engaging with industry groups and standards organizations. Use test planning to streamline development and meet regulatory expectations efficiently. Questions to Ponder for the Future How will integrating advanced hazard mitigation strategies impact device innovation? What role will emerging technologies like AI and IoT play in future standards revisions? How can smaller MedTech companies effectively adapt to these significant changes? MedTech 101: Understanding IEC 60601 For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices. References and Resources Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601: Visit Eisner Safety Consultants Etienne Nichols’ LinkedIn – Connect here Submit comments to standards – Contact your national committee or regulatory body for IEC SC62A involvement. Audience Poll: What aspect of the IEC 60601 update concerns you most—testing, design changes, or regulatory approval? Share your thoughts by emailing us at podcast@greenlight.guru . Sponsor Segment This episode is brought to you by Greenlight Guru , the leading QMS software for the MedTech industry. Simplify compliance and accelerate innovation with tools tailored to your needs. Visit www.greenlight.guru to schedule a demo today and start your journey toward easier compliance! Feedback and Reviews Love the podcast? Leave us a review on iTunes! It helps others find us and improves our content. For feedback or topic suggestions, email us at podcast@greenlight.guru . Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!…

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#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues 51:18

πριν 18 weeks51:18

51:18

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities. Key Timestamps: 00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message 03:15 – Introduction to Dr. Mike Drues and his background in PMAs 05:45 – Overview of PMAs and when they should be used 11:30 – Are PMAs the only pathway for Class 3 devices? 16:20 – Types of PMAs: Traditional, Modular, and Streamlined 22:40 – Advantages of PMAs compared to 510(k)s and de novos 27:50 – The strategic use of predicates in the PMA process 33:00 – Clinical data requirements and misconceptions for PMAs 41:10 – Post-market requirements and differences for PMA devices 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals 54:30 – Final thoughts on overcoming industry resistance to PMAs Standout Quotes: "Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues "Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues 3 Key Takeaways: PMA Isn’t the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden. Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market. Clinical Data Isn’t Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies. References: Previous Greenlight Guru Webinars by Dr. Mike Drues Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements. Audience Engagement: Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you anticipate?" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko 33:48

πριν 19 weeks33:48

33:48

In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt. Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape. Key Timestamps: 00:00 – Introduction and Greenlight Guru sponsor message 02:45 – Welcoming Justin Bushko; background in MedTech and engineering 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing 10:45 – Prototyping with a purpose: Ensuring design iterations target risks 16:00 – Balancing innovation, user needs, and cost-effectiveness 20:30 – Defining essential versus “nice-to-have” features in MedTech 26:45 – Strategic pivots in MedTech: When and why to change course 32:50 – The critical role of design freeze and usability studies 39:10 – Lessons from competitive benchmarking and reverse engineering 46:25 – Handling unique challenges in regulated industries like MedTech 52:15 – Opportunities for MedTech innovation and faster regulatory approvals 58:45 – Advice for founders and importance of building the right team Standout Quotes: "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko "MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko 3 Key Takeaways: Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages. Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration. References: Connect with Justin Bushko on LinkedIn Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements. Audience Engagement: Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell 58:38

πριν 20 weeks58:38

58:38

In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence. The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering listeners a wealth of actionable takeaways for navigating regulatory challenges and accelerating market access. Key Timestamps: 00:01 – Introduction to Greenlight Guru’s QMS capabilities 03:15 – Setting the stage: Why verification and validation matter 08:30 – Differences between verification and validation explained 12:50 – Importance of strong user needs and design inputs 23:45 – Writing effective user needs and identifying users 33:00 – Creating robust design inputs and their sources beyond user needs 40:10 – From design inputs to design outputs: Key considerations 48:20 – Best practices for conducting design reviews and managing revisions 57:15 – Verification strategies: The importance of pre-verification 01:05:40 – Common challenges in V&V, including sample sizes and justifying tests 01:15:10 – Using feedback during testing and leveraging observations 01:23:00 – Final takeaways and practical advice for V&V success Standout Quotes: "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell 3 Key Takeaways: Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended. Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins. Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing. References: Devon Campbell’s Consulting – Connect with Devon for more insights on product development. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements. Audience Engagement: Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences below!" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq 35:58

πριν 21 weeks35:58

35:58

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a well-designed roadmap serves as a guiding document for market access and investor confidence. The conversation delves into how to navigate complex market regulations, assess classification and compliance needs, and identify opportunities for strategic global market entry. Adnan’s 25+ years of experience provide actionable insights for medtech startups and established companies alike. Key Timestamps: 00:02 – Introduction to Greenlight Guru and Episode Overview 03:10 – Introducing Adnan Ashfaq and his background in medtech 04:45 – Difference between a regulatory strategy and regulatory roadmap 07:00 – What a regulatory roadmap is and why it’s crucial 12:30 – When and why companies need a regulatory roadmap 16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines 23:20 – Importance of classification and its impact on the regulatory path 28:50 – Integrating QMS, clinical investigations, and stakeholder engagement 36:00 – Leveraging a roadmap for strategic market entry and global reach 44:15 – Pitfalls to avoid in creating a regulatory roadmap 54:20 – Using language and intended use statements strategically 01:03:00 – Wrapping Up: Takeaways and Advice for MedTech Professionals Standout Quotes: "A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq "Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq 3 Key Takeaways: Regulatory Roadmaps Are Essential: Developing a roadmap early in the process ensures clear regulatory pathways, cost assessments, and market prioritization, helping avoid costly missteps later. Market Entry Strategy Matters: Strategic use of market-specific regulations, such as leveraging faster access opportunities in some regions, can enhance commercialization efforts and post-market success. Language and Classification Are Crucial: Precise language in defining your device's intended use and claims can significantly impact classification, regulatory requirements, and market access speed. References: Simpli Medica – Adnan Ashfaq’s consultancy website. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Regulatory Roadmap – A strategic document that outlines the costs, timelines, market-specific regulatory requirements, and resources necessary for bringing a medical device to market. Different from a regulatory strategy, it focuses on broader market entry planning and serves as a valuable tool for investor engagement and commercial success. Audience Engagement: Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and how it impacted your journey!" Feedback: Enjoyed this episode? Have questions or topics you’d like to hear more about? Reach out to us at podcast@greenlight.guru . Don’t forget to leave us a review—it helps us improve and reach more medtech professionals.…

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#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli 37:14

πριν 22 weeks37:14

37:14

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity. This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success. Key Timestamps: 00:02 – Intro to Greenlight Guru and Episode Topic 03:30 – Introducing Ashkon Rasooli and his background 05:15 – Defining the “Non-BS QMS” approach 06:45 – Principle #1: Quality Over Proceduralism 12:00 – Navigating deviations in QMS and avoiding extremes 14:45 – Principle #2: Culture Over Mandate 22:10 – Principle #3: Redundancy Over Duplication 29:30 – Principle #4: Conciseness Over Verbosity 37:00 – The Importance of Designing for Regulatory and Quality from the Start 46:30 – Tactical QMS advice for new medtech founders 57:00 – Wrapping Up and Key Takeaways Standout Quotes: "There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli "A QMS should serve quality and compliance, but it has to be intuitive for every person in your company. Complexity does not mean quality." – Ashkon Rasooli 3 Key Takeaways: Quality Over Proceduralism: Focus on the intent and impact of QMS processes rather than rigid adherence to procedures that may not reflect the realities of your business. Culture Over Mandate: Building a culture of quality involves engaging every employee, not just those in quality roles, to ensure shared responsibility and proactive efforts. Design for Quality Early On: Engaging with quality and regulatory advisors at the architecture and design phase can prevent costly rework and optimize compliance pathways. References: Ashkon Rasooli on LinkedIn Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software: www.greenlight.guru MedTech 101: QMS (Quality Management System) – A structured system of procedures and processes covering all aspects of design, development, manufacturing, and distribution to ensure product safety, effectiveness, and regulatory compliance. Essential for medtech companies seeking to market devices in most global markets. Audience Engagement: Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!" Feedback: Love this episode? Have ideas or topics you want us to cover? Email us at podcast@greenlight.guru and leave a review to help others discover the Global Medical Device Podcast.…

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#389: Pre-determined Change Control Plans 44:10

πριν 23 weeks44:10

44:10

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes. Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies. Key Timestamps: [03:15] Introduction to PCCPs and Change Management [08:40] PCCP’s origin and application for AI-driven devices [14:20] Expansion of PCCPs to all medical devices [25:10] Practical challenges and best uses for PCCPs [34:55] Submitting PCCPs: Considerations and tips [45:30] Potential of PCCPs for non-software devices: 3D-printed knees case [52:40] FDA guidance and limitations for label changes [1:06:20] Final recommendations and quality system implications for PCCPs Memorable Quotes: “PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn’t a blank check. It’s a pre-validation of boundaries.” — Mike Drues Top Takeaways: Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays. Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster. Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations. References: Mike Drues on LinkedIn FDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissions MedTech 101: Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types. Audience Engagement: Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications? Feedback: We’d love your thoughts on the PCCP framework! Email us at podcast@greenlight.guru with your feedback, questions, or ideas for future topics. Sponsors: Special thanks to Greenlight Guru — the industry’s eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru .…

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#388: Elements of an Effective CAPA Program 38:35

πριν 24 weeks38:35

38:35

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive meaningful improvement within medical device companies. With over a decade of experience, Georg brings practical knowledge on avoiding common pitfalls such as "death by CAPA" or failing to recognize high-risk systemic issues. The episode also delves into the importance of verification of effectiveness (VoE) checks, the distinctions between corrective actions and preventive actions, and how to balance a proactive approach with pragmatic solutions. Key Timestamps: [03:15] – Defining CAPA and its critical role in Quality Management Systems [10:45] – Common CAPA triggers: Balancing overuse and underuse [18:20] – Root cause analysis vs. corrective action: A step-by-step approach [25:40] – Containment vs. correction: Key differences in addressing nonconformities [38:10] – Verification of effectiveness: Best practices for ensuring long-term solutions [50:30] – Continuous improvement through CAPA: Avoiding system overload [1:00:05] – Practical tips for balancing CAPA triggers with company priorities Memorable Quotes: “CAPA isn't just about compliance; it's about driving real improvement in your organization." – Georg Digel “The worst thing that can happen is losing oversight on the serious issues because your system is flooded with trivial ones.” – Georg Digel “Root cause analysis isn’t about fixing the symptom, it’s about ensuring the issue never comes back.” – Etienne Nichols Key Takeaways: MedTech Trends: CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues. Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions. Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management. Practical Tips for CAPA Implementation: Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues. Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success. Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites. Future Questions in MedTech: How will advances in AI and machine learning improve CAPA systems in the future? Can companies move toward more preventive action frameworks, or is CAPA inherently reactive? How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing? References: FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors. LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights on improving CAPA systems. Etienne Nichols LinkedIn – Connect with Etienne Nichols for further discussions on CAPA and MedTech trends. MedTech 101: CAPA Systems CAPA stands for Corrective and Preventive Action. It is a crucial part of any Quality Management System (QMS), designed to investigate and address nonconformities (errors or defects) in medical devices. Corrections fix the immediate problem, while corrective actions aim to stop it from happening again. CAPA ensures continuous improvement and regulatory compliance for medical device manufacturers. Audience Poll: Which aspect of CAPA do you find most challenging in your company? Identifying CAPA triggers Conducting root cause analysis Implementing corrective actions Verification of effectiveness Share your thoughts or any questions at podcast@greenlight.guru ! Feedback Call-to-Action: Enjoyed this episode? We’d love to hear your thoughts! Leave a review on iTunes, and feel free to email us at podcast@greenlight.guru with any feedback or suggestions for future topics. Your feedback helps us grow and deliver even better content. Sponsor Mentions: Greenlight Guru – Streamline your quality management with Greenlight Guru's eQMS, a comprehensive system designed for medical device companies. Say goodbye to spreadsheet chaos and hello to efficiency! Check it out at Greenlight Guru . Rook QS – Scaling fast? Rook QS offers quality-as-a-service solutions tailored to growing medical device companies, helping you maintain compliance through every stage. Learn more at rookqs.com .…

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#387: The case for Real World Evidence Studies 29:06

πριν 25 weeks29:06

29:06

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and lower costs for MedTech companies. With a focus on post-market data, off-label use, and pivotal test cases like pediatric devices and robotic surgery, this conversation reveals the immense potential of RWE to improve patient outcomes and advance medical innovation. Simon also touches on the evolution of NEST since its creation under the FDA's MDUFA commitment and provides real-world examples of how RWE has led to FDA clearances, including collaborations with industry giants like Johnson & Johnson and Intuitive Surgical. Key Timestamps: [00:02:05] – Introduction to Simon Mason and NEST's mission. [00:06:30] – The importance of real-world evidence in medical device submissions. [00:10:50] – NEST's relationship with FDA and industry stakeholders. [00:18:25] – Real-world examples: How RWE led to device clearances. [00:25:10] – Challenges in using real-world data for submissions. [00:32:45] – NEST's role in pediatric devices and the potential for off-label approvals. [00:38:30] – The financial and time-saving benefits of using real-world evidence. [00:50:00] – How companies can engage with NEST to accelerate device approvals. Quotes: Simon Mason : “Real-world evidence has the potential to accelerate device approval and save millions in clinical trial costs. It's all about leveraging existing data to support regulatory submissions.” Etienne Nichols : "The opportunity to use off-label real-world data to expand indications opens a whole new world of innovation for MedTech companies." Simon Mason : “Speed is everything in business and in patient care. RWE is all about moving faster while maintaining safety and effectiveness.” Key Takeaways: Latest MedTech Trends: Real-World Evidence (RWE) Revolution : RWE is transforming regulatory pathways by utilizing data already being collected in real-world settings, reducing the need for costly clinical trials. Off-Label Use for Approvals : NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications. FDA Collaboration : NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies. Practical Tips for MedTech Innovators: Engage Early : Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities. Data Accessibility : Companies should explore existing registries or datasets that could support their submissions, saving time and resources. Clear Project Goals : When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them. Questions for Future Development: How will the widespread adoption of RWE change the landscape for early-stage MedTech startups? Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials? What role will AI play in streamlining data collection and analysis for real-world evidence? References: MDIC (Medical Device Innovation Consortium) – NEST's parent organization, which coordinates efforts between FDA and industry stakeholders. MDIC Innovators Forum , held April 8-9, 2025 in Washington, D.C. This is the annual event discussing the latest developments in real-world evidence and device approvals. Etienne Nichols' LinkedIn – Connect with Etienne for insights on MedTech innovation. MedTech 101: What is Real-World Evidence (RWE)? Real-world evidence refers to the clinical evidence regarding the usage and potential benefits or risks of a medical device, derived from analysis of real-world data (RWD) gathered outside of traditional clinical trials. RWE is often collected from registries, electronic health records, and off-label device use, and can significantly speed up regulatory processes by leveraging data already in existence. NEST : The National Evaluation System for Health Technology, under MDIC, is a non-profit initiative funded by FDA and MedTech companies to enhance the use of RWE for medical device regulatory submissions. Audience Poll: What do you think is the biggest advantage of using real-world evidence for medical device approval? Faster time-to-market Lower costs More accurate data Email your responses to podcast@greenlight.guru ! Discussion Question: With real-world evidence becoming a critical part of regulatory pathways, how do you see the future of medical device approvals evolving? Will traditional clinical trials become obsolete? Feedback Call-to-Action: We’d love your feedback! Leave us a review on iTunes, or send your thoughts and suggestions to podcast@greenlight.guru . Your input helps us improve and bring more valuable content to the MedTech community. Sponsor Segment: Today's episode is brought to you by Greenlight Guru and Rook Quality Systems . Greenlight Guru is the quality management (QMS) and electronic data capture (EDC) software designed specifically for medical device companies. From design controls to post-market surveillance, Greenlight Guru helps you stay compliant with FDA and ISO standards, ensuring your device reaches the market faster and safer. Visit greenlight.guru to learn how their QMS can help your MedTech innovation thrive. Rook Quality Systems offers customized Quality-as-a-Service solutions for MedTech companies. Whether you need compliance support, process optimization, or help with regulatory submissions, RookQS tailors their services to meet your unique needs. Learn more about how they can elevate your quality management system by visiting rookqs.com . Both Greenlight Guru and RookQS are committed to helping you bring life-changing medical devices to market efficiently and effectively.…

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#386: The Danger of In-Home Use Medical Devices, Pt. 2 52:49

πριν 26 weeks52:49

52:49

In this episode of the Global Medical Device Podcast , host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare professionals, face unique hurdles such as user training, environmental factors, and technological concerns like cybersecurity and data security. Together, Etienne and Mike also delve into how regulatory frameworks need to adapt for home use, and they highlight potential future issues with devices as AI and robotic assistance grow in prominence. Key Timestamps: [02:20] - Recap of Part 1 & Introduction to Home Use Devices Mike revisits key topics from part 1, focusing on why home use devices matter. [10:45] - Defining the Intended User and Environment Discussion about how labeling must account for who will use the device and where. [15:30] - Technological and Environmental Challenges for Home Use Devices Exploring temperature, humidity, and power inconsistencies affecting performance. [30:05] - Reprocessing and Cleaning Devices at Home The challenges and risks associated with reusing and cleaning devices like CPAPs. [40:15] - Usability Testing & Human Factors Importance of considering non-healthcare users when designing home devices. [55:12] - Cybersecurity Risks in Home Devices The growing significance of data security and strategies for protecting devices in non-clinical settings. [1:05:30] - Post-Market Surveillance and Reporting for Home Devices The complexities of tracking device performance and recalls when used in home environments. Memorable Quotes: "When we talk about intended users, we must shift our thinking from healthcare professionals to patients. Designing for non-clinicians is crucial because usability directly impacts safety." – Mike Drues "If your device has to be recalibrated, why not have a mechanism that disables it when calibration is overdue? That’s a much stronger safeguard than relying on users to remember." – Mike Drues "Cybersecurity is a growing challenge in home devices. It’s not just about protecting personal data—imagine if a critical medical device was hacked." – Etienne Nichols Key Takeaways: Latest MedTech Trends: Increasing Use of Home Medical Devices : Patients are increasingly managing their own health at home, necessitating devices that are user-friendly and adaptable to various home environments. AI & Robotics in Home Devices : With the rise of AI and robotic assistance, the definition of an "intended user" is evolving, requiring future-proof regulatory considerations. Data Security : As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies. Practical Tips for MedTech Professionals: Understand the End-User : When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key. Incorporate Environmental Testing : Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase. Push Updates Automatically : For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull them. References: FDA Guidance on Home Use Devices : Relevant guidelines shaping the regulatory landscape for home use devices. Philips Respironics CPAP Recall : A case study highlighting the importance of post-market surveillance and recalls. Etienne Nichols’ LinkedIn Profile : Connect with Etienne MedTech 101: Home Use Medical Devices For new listeners, home use medical devices are designed for patient self-administration and management outside of a clinical setting. Examples include CPAP machines, blood glucose monitors, and wearable heart monitors. These devices must meet stringent usability and safety standards, as patients using them often lack formal medical training. Key considerations in the design and regulation of these devices include labeling (clear instructions), user environment (temperature, lighting), and cybersecurity risks. Discussion Question: What technological advancements do you think will have the most significant impact on the future of home healthcare? Let us know by emailing us at podcast@greenlight.guru ! We'd love feedback: Enjoyed the episode? Leave us a review on iTunes—it helps others find us and lets us know how we're doing! Have thoughts or suggestions for future episodes? Reach out to us at podcast@greenlight.guru or connect with Etienne on LinkedIn. Sponsor Message: This episode is brought to you by Greenlight Guru , the only quality management system (QMS) built specifically for medical device companies. Streamline your quality processes and get to market faster with Greenlight Guru’s easy-to-use platform. Visit www.greenlight.guru for a free demo today! This episode is also sponsored by Rook Quality Systems . Documentation is key to a successful quality management system, and Rook Quality Systems helps you create and maintain clear, compliant Standard Operating Procedures (SOPs) and other essential documents. Their team of experts ensures your documentation aligns with regulatory standards, making audits easier and your processes more efficient. Start optimizing your quality management system today at rookqs.com .…

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#385: The Trouble with Home-Use Devices, Pt. 1 36:20

πριν 27 weeks36:20