Medical Devices

The application of GMP – good manufacturing practices – is required in medical device production as well. Companies supplying their medical devices to the USA know this. There GMP is established and anchored in law as a quality assurance system through 21 CFR 820. In Europe the concept has not yet been solidified this way in connection with medical devices. But the underlying topics certainly are.  

Risk management related to process or other risk analyses, qualification, validation of production or cleaning processes, measuring equipment capability studies, software validation or the validation of relevant computer-based systems just to name a few select topics: gempex is an experienced and competent partner for the implementation of GMP requirements in compliance with regulations but nevertheless pragmatically, especially in the medical device sector. 

Select Service Examples^*

• New Facility for Manufacturing and Packaging Dental Products
  Risk management support and implementation
• Preparation and Follow-up for an FDA Inspection of a Medical Device Manufacturer
  CAPA processing, implementation of quality assurance measures, risk analyses, qualification, validation, preparation of SOPs  
• New Facility for Manufacturing Medical Devices in the IVD Sector
  Development, introduction and implementation of a generic validation concept
• Production of Orthopaedic Implants
  Planning, coordination and implementation of a location-wide GMP training concept

^* We will gladly provide you with specific references on request.