Guest user Created: Oct 25, 2023 Last commented: Oct 25, 2023

Regulatory Compliance QMS Program

Please provide a regulatory compliance QMS program specifics contents laid out in a document which is required for a high risk complex class III medical device PMA approval for US FDA and European countries.

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Kristina Zvonar Brkić Oct 25, 2023

In our ISO 13485 & MDR toolkit, we have a complete list of documents as well as the project plan for how to implement it. This toolkit is applicable to all classes of medical devices under the MDR. Although this toolkit is not directly applicable to PMA approval, certain documents can be used.

You can download the complete list of documents on the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

More details regarding the differences and similarities between the US and EU markets are discussed in this article:

FDA vs. EU MDR Technical Documentation Matrix https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix

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Oct 25, 2023

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