EU MDR – The essentials you need to know, Post Market Surveillance (PMS) and Technical Documentation (TD).

Previously in the Directive 93/42/EEC ‘Post Market Surveillanceappeared once, twice, maybe three times… The Regulation mentions it more than 60 times!

The increased focus is clear to all and especially manufacturers of devices class IIa and higher should be aware of the new requirements.

As we all know PMS can be used for good business or can be really bad business, depending on how you handle it.

Download Whitepaper on PMS & TD here


Questions about this topic and your device – contact
Randi Hauerberg
Principal Advisor/Team Lead
Regulatory Affairs & Quality Management
Connect with me on LinkedIn

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