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Impact of Adopting ISO 13485 in New QMSR for Medical Devices, Part 1
Manage episode 484421362 series 3667451
In this episode of the Quality Grind Podcast, presented by Medvacon, Mike Kent welcomes Armin Beck, a consultant in the medical device field, to discuss FDA's recent adoption of ISO 13485 as part of its amended Quality Management System Regulation. This change, effective February 2, 2026, reinforces the FDA’s focus on harmonizing US regulations with global standards. The conversation covers the implications for medical device companies, including the expansion of FDA access to audit reports and Quality Management Review records, as well as potential new agency inspection and oversight tactics. The episode also highlights the importance of Risk Management under ISO 13485 and how organizations can adapt to these new requirements. Tune in to learn the steps your company can take to navigate these changes effectively.
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Chapters
1. Introduction to the Quality Grind Podcast (00:00:00)
2. Meet Our Special Guest: Armin Beck (00:00:24)
3. Understanding ISO 13485 Adoption by FDA (00:01:39)
4. Challenges and Benefits of Harmonizing Regulations (00:03:24)
5. Implications for CAPA and Quality Management (00:06:12)
6. Risk Management Under ISO 13485 (00:19:19)
7. Conclusion and Upcoming Topics (00:25:01)
31 episodes
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