PMS planning and Challenges under EUMDR
While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD), it was not defined clearly in the MDD. 1 min
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invitro diagnostic medical device regulation
What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).Our IVD team has a... 1 min
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Medical Device Labeling Compliance Solutions|Medical Device Patient Labeling services
Labeling can be challenging and today’s medical device manufacturers are faced with a range of evolving requirements and regulations such as UDI, that complicate the 1 min
