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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.

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• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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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.

Contact MEDVACON

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us to daily updates on blogs and podcasts! @medvacon on all platforms!

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In this episode of the Quality Grind Podcast, host Mike Kent and Medvacon consultant Kim Lim round out their exploration of Technology Transfer, identifying the critical strategies that foster a smooth execution process. Discover the value of thorough preparation, the significance of quality agreements, and the role of process performance qualifications (PPQ). Emphasis is placed on maintaining transparent and frequent communication between sponsors and contract partners, as well as fostering strong interdepartmental relationships. Tips for managing documentation and data are also highlighted to prevent pitfalls and ensure the creation of high-quality products. Perfect for anyone looking for actionable tips and expert advice!

Contact MEDVACON

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us to daily updates on blogs and podcasts! @medvacon on all platforms!