MDR Conformity Assessment Routes:

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MDRChats-by ChatMDR

ChatMDR

20 episodes

1 week ago

MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.

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MDR Conformity Assessment Routes:

MDRChats-by ChatMDR

7 minutes 55 seconds

1 year ago

MDR Conformity Assessment Routes:

In this episode of MDRChats, host Oliver Harris interviews medical device compliance expert Dr. Emma Lawson to clarify the differences between Annex 9, Annex 10, and Annex 11 under the Medical Device Regulation (MDR). They delve into the various conformity assessment options, discuss how manufacturers can decide which route to take, and shed light on this often confusing topic for professionals in the industry.