In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.

Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.

The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US’s stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.

1. 01:45 – The shift from "checkboxing" to a risk-based approach.
2. 03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.
3. 04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.
4. 06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.
5. 08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.
6. 12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.
7. 13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.
8. 15:30 – Why the US voted "No" on the current draft: A call for better guidance.
9. 18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."
10. 21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).
11. 25:40 – Advice for small vs. large companies on building material databases.

1. Lifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.

The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.

Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.

1. 00:00 - Introduction to QMS requirements and guest Mike Drues.
2. 03:45 - The core sections of a QMS according to the Quality System Regulation.
3. 05:12 - Why the QSR list is a starting point, not a stopping point.
4. 08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.
5. 10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?
6. 13:15 - Understanding the timing and strategy for FDA Establishment Registration.
7. 15:40 - The Triage Approach: Which QMS sections matter most during early development?
8. 19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.

1. Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
2. Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.
3. Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.

Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.

The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.

1. 01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.
2. 04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.
3. 06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.
4. 08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.
5. 12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.
6. 15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.
7. 19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.
8. 22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.

1. Right-Size Autonomy: Match the AI’s level of independence to the risk of the application. High-risk diagnostic tools should have lower autonomy (Level 1-2), while administrative tools can operate more freely.
2. Implement Redundancy: Use a "two is one" approach by employing an independent AI verification agent to check the primary model’s output against safety guidelines before it reaches the user.

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.

The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.

Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.

1. 00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.
2. 01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.
3. 04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.
4. 05:45 - Dr. Hoffmann’s personal origin story: Being one of the first IVF babies in the U.S.
5. 08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.
6. 10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.
7. 14:39 - Defining SOS moments: Turning distress signals into leadership strengths.
8. 18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.
9. 20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.
10. 25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.
11. 28:52 - The power of storytelling for engineers and data-driven professionals.

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare.

The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends.

"Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli

• 00:00 - Introduction to AI in MedTech
• 05:15 - Discussing AI's deterministic vs. statistical nature
• 12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology
• 20:45 - Wearable health monitors and patient-driven health data
• 28:10 - The role of AI in medical device operations and manufacturing
• 35:00 - AI at the point of care: Enhancing patient and clinician experience
• 42:15 - Regulatory challenges and the future of AI in healthcare

Key Takeaways:

1. Latest MedTech Trends:

• The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.
• Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.

2. Practical Tips for MedTech Enthusiasts:

• Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.
• Consider the ethical implications and ensure bias mitigation in AI model training and deployment.

3. Predictions for the Future:

• Increased adoption of AI across various healthcare sectors, including surgery and patient care management.
• Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.

References:

• Ashkon Rasooli on LinkedIn
• ashkon@engeniussolutions.com
• Engenius Solutions
• AFDO/RAPS Working Group
• Etienne Nichols on LinkedIn

Sponsors:

This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guru

Share your thoughts and questions with us at podcast@greenlight.guru

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.

• [00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.
• [00:03:30] Jennifer's origin story in quality and regulatory roles.
• [00:07:15] The pivotal learning moments in quality management and regulatory affairs.
• [00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.
• [00:16:30] The significance of human factors in product design and learning from end-user feedback.
• [00:21:50] Project management skills for quality and regulatory professionals.
• [00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.
• [00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.

• "A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor
• "It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-Tudor

1. An emphasis on proactive quality management to ensure patient safety and product efficacy.
2. The rising importance of human factors and user-centered design in medical device development.
3. The shift towards integrating software and digital solutions in medical devices.

1. Quality and regulatory professionals should hone their project management skills.
2. Communication and storytelling are key in influencing business decisions and leadership.
3. Always present solutions and alternatives when addressing compliance challenges.

• JMT Compliance Consulting
• Jennifer Mascioli-Tudor on LinkedIn
• Etienne Nichols on LinkedIn
• Greenlight Guru’s platform for Quality Management & Clinical Investigations

• Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"

• Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.

The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA’s ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.

Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.

• 00:00 – Introduction and Michelle Wu’s background in MedTech and AI.
• 03:45 – A founder’s perspective: Michelle’s personal experience in the OR seeing her clients' devices.
• 08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.
• 11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.
• 15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.
• 18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.
• 22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.
• 27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.
• 31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.

• AI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.
• The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.
• The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").
• Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.

• Nyquist AI: Michelle Wu’s platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.
• FDA ELSA: The...

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.

The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.

Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).

1. [0:50] QMSR: The biggest shakeup to US quality requirements since 1996.
2. [2:00] Effective Date: February 2, 2026—the clock is ticking.
3. [2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.
4. [3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).
5. [5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).
6. [6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).
7. [7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).
8. [8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.
9. [10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.
10. [13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.
11. [17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).