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Latest Episodes
#388: Elements of an Effective CAPA Program
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 lik
#387: The case for Real World Evidence Studies
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
#386: The Danger of In-Home Use Medical Devices, Pt. 2
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, us
#385: The Trouble with Home-Use Devices, Pt. 1
In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for device
#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory e
#383: What Standards Apply to My Device?
In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of
#382: Design of Experiments - How and When to Use DOE
In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solv
#381: MedTech Advice from an Accidental Entrepreneur
In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how
#380: Navigating the Complex World of Combination Products with Subhi Saadeh
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate
#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer
In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier