Notified Body Audits Are Changing

OMEDtechNews & Events0 Comments

News from the Medical Device Notified Body Meeting in Brussels:

 

Notified Bodies are being advised to use their existing authority to conduct more unannounced inspection visits to manufacturers, conduct product sampling, witness device testing during audits, and perform market surveillance. Guidance is expected to be developed and issued to Notified Bodies on these practices soon.

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