PROSYSTEM supports medical device manufacturers and suppliers with the implementation of the essential requirements of the Quality Standard ISO 13485:2003 + AC 2009

Quality System Audits (21 CFR 820 and ISO 13485:2003 + AC:2009)

Extend your quality management system to your external suppliers.

FDA is required to periodic inspect medical device manufacturers for the compliance to the Good Manufacturing Practice (GMP).

Medical deivce manufacturers intending to market their devices in the United States have to fulfill the FDA Quality System Regulation 21CFR820 (Good Manufacturing Practice) quality management requirements.