Clean Room Validation
Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct…
Field Safety Corrective Actions : EU MDR Requirements
Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related…
Supplier Management and Regulatory Compliance: Key Aspects
Supplier management is a key aspect for any type of organizations, including medical device companies that often have to outsource…
IVDR 2017/746 : In Vitro Diagnostic Regulation
The IVDR – In vitro Diagnostic Regulation 2017/746 – will enter into force in 2022 but it is very important…
