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Impact of Adopting ISO13485 in New QMSR for Medical Devices, Part 2
Manage episode 484421361 series 3667451
In this episode of the Quality Grind Podcast, host Mike Kent continues his discussion with Medvacon consultant Armin Beck about the newly amended 21 CFR 820, Quality Management System Regulation for medical devices. The duo explores the implications of new FDA inspection techniques, the importance of thorough gap analyses for readiness, and the increased responsibility of executive management in quality oversight. The lens widens to discuss the potential impact on not just medical device firms but also the broader Life Sciences industry. The episode also offers practical guidance and resources to help organizations align with the new requirements and avoid regulatory pitfalls.
Contact MEDVACON:
- Message us at @MedvaconLifeSciences on LinkedIn
- Visit our website at www.medvacon.com/contact
- Email us at [email protected]
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Chapters
1. Introduction to the Quality Grind Podcast (00:00:00)
2. Recap and Key Updates on 21 CFR 820 (00:00:26)
3. Impact of New FDA Inspection Process (00:01:43)
4. Executive Management's Role in Compliance (00:05:11)
5. Preparing for Regulatory Changes (00:10:19)
6. Broader Implications for Life Sciences (00:11:41)
7. Strategies for Readiness and Compliance (00:18:45)
8. Conclusion and Final Thoughts (00:26:48)
26 episodes
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