Скачать или смотреть Traceability for Implantable Devices | DP Minutes QMSR Comment #48

Welcome to our YouTube channel! We’re excited to bring you another episode of "DP Minutes," where we delve into crucial updates and insights from the medical device industry.

In this DP Minute, Darren from DP Distribution & Consulting, LLC® explores Comment No. 48 from the QMSR Preamble. This comment addresses traceability for implantable devices. The FDA has clarified that, despite changes in wording from the QS Regulation to ISO 13485 clause 7.5.9, the expectations for manufacturers of life-sustaining devices remain unchanged.
Curious about how these traceability requirements might impact your devices? Watch the video to get a comprehensive overview of the FDA’s expectations and ensure your compliance.

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