Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct impact on patient safety and product quality. Building a cleanroom

Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related to the impact of this process to the safety of

Supplier management is a key aspect for any type of organizations, including medical device companies that often have to outsource manufacturing operations or other type of activities. From regulatory standpoint, ISO

The IVDR - In vitro Diagnostic Regulation 2017/746 - will enter into force in 2022 but it is very important to discuss since now the changes that this new regulation