Global Medical Device Podcast in 2024
47 episodes, newest first.
- 19 Dec#396Mastering Device Descriptions: The Cornerstone of Medical Device Submissions50m
- 12 Dec#395IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond42m
- 6 Dec#394Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues51m
- 29 Nov#393Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko33m
- 22 Nov#392Verification and Validation in MedTech: A Practical Guide with Devon Campbell58m
- 14 Nov#391Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq35m
- 7 Nov#390Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli37m
- 31 Oct#389Pre-determined Change Control Plans44m
- 24 Oct#388Elements of an Effective CAPA Program38m
- 17 Oct#387The case for Real World Evidence Studies29m
- 10 Oct#386The Danger of In-Home Use Medical Devices, Pt. 252m
- 4 Oct#385The Trouble with Home-Use Devices, Pt. 136m
- 26 Sept#384Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends44m
- 19 Sept#383What Standards Apply to My Device?51m
- 12 Sept#382Design of Experiments - How and When to Use DOE42m
- 5 Sept#381MedTech Advice from an Accidental Entrepreneur43m
- 30 Aug#380Navigating the Complex World of Combination Products with Subhi Saadeh38m
- 15 Aug#379Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer36m
- 8 Aug#378Who Owns the Design Controls Process?34m
- 25 Jul#377Designing a Medical Device for a Global User43m
- 18 Jul#376FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights39m
- 11 Jul#375Direct to Consumer - The Future of Healthcare47m
- 25 Jun#374Clinical Evidence - The Key to Market Adoption47m
- 6 Jun#373Creative Clinical Recruitment49m
- 4 Jun#372Getting Hired In MedTech53m
- 30 May#370Meet a Guru: Jamie Bihary32m
- 28 May#371Achieving ISO 13485 Certification45m
- 23 May#369Advice to Medical Device Inventors43m
- 21 May#368Institutional Review Boards (IRBs)49m
- 16 May#367Interviewing the Interviewer39m
- 9 May#366Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List55m
- 7 May#365Medical Device Reporting: The Do's and Don'ts40m
- 2 May#363Bringing a Self-Funded Medical Device to Market39m
- 30 Apr#364Building a Partnership with your Regulatory Consultant40m
- 25 Apr#362Managing Risk in Clinical Investigations39m
- 19 Apr#361Speaking the Language of IVD44m
- 11 Apr#360Is It Possible to "Buy" a QMS?32m
- 4 Apr#359Project Management in MedTech1h 02m
- 21 Mar#358FDAs Voluntary Improvement Program28m
- 7 Mar#357The State of UDI Across the World52m
- 22 Feb#356Quality Myths & Lessons Learned Part II46m
- 15 Feb#355Mastering the Pitch: MedTech Innovations from Concept to Market40m
- 7 Feb#354Advice for MedTech Regulatory Affairs Professionals44m
- 30 Jan#353How Artificial Intelligence is Impacting the MedTech Industry45m
- 18 Jan#352Fundamentals of Quality & Regulatory50m
- 11 Jan#351The State of AI & Clinical Investigations39m
- 4 Jan#350The Evolving Landscape of AI in MedTech49m