Episode #41 of / "Clarissa's Medical Compliance /". In this episode, Clarissa Benfield hosts Alexander Crosby, Americas Medical Program Director for Intertek Business Assurance, to discuss the final ruling on the 21 CFR 820 regulation, which goes into effect in February 2026. They dive into the FDA's decision to align with ISO 13485. , which reflects a significant shift toward global harmonization and emphasizes the importance of quality management systems that go beyond compliance. Manufacturers are encouraged to begin preparations now to comply with the new standards and ensure a smooth transition.

/"Medical Compliance With Clarissa/" is a podcast series hosted by Clarissa Benfield, Global Medical Director of Intertek. Each episode features an expert from the world of product compliance, including electrical safety, radio and wireless, EMC, cybersecurity, hazardous chemicals and many more topics governed by agencies such as the FDA, Health Canada, etc. Tune in for more episodes to every few weeks, and check out https://www.intertek.com/medical/resources for a wide range of informative factsheets, webinars and whitepapers to help you meet all your regulatory and compliance needs.

https://www.intertek.com/medical

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