The Medical Device Single Audit Program (MDSAP) allows for medical device manufacturers to undergo a single regulatory audit that covers the...
IVDR (In Vitro Diagnostic Regulation) impacts all in vitro devices sold in EU markets. Learn what this means for you.
The definitions of ‘process approach’ and ‘risk management’ in ISO 13485:2003[i] have definitely left some gray areas for organizations over the...
As a quality manager in the medical device or pharmaceutical manufacturing industries, you surely understand the importance of planning ahead for...
Are you a supplier to pharmaceutical and medical device companies? If so, you should be taking a hard look at your own supplier diversity...
Whether your company manufactures pharmaceuticals or medical devices, your goal as a Quality manager should be to create a culture of quality so...
