Medical Devices

Quality and Compliance

Quality in medical device manufacturing and testing means many things to many people. In addition to FDA and EMA guidance and regulation, there are ISO, ANSI and ASTM directives and standards which often come in to play. The devil is in the details, but some basic good practices can be employed to satisfy the myriad requirements. We bring a systems approach to implementing Quality operations for medical device development and manufacturing. This perspective has allowed us to help guide products from development through commercials stages in the US, European and various Asian regulatory environments.