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Medical Auditing
Are you looking for help with navigating the regulatory challenges of the future in order to participate effectively in the marketplace? With more than 300 locations in almost 50 countries, TÜV Rheinland of North America Inc. with its affiliated offices has a global view of the ever changing requirements of the most important markets in the world. TÜV Rheinland Product Safety GmbH as a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices, TÜV Rheinland is the partner you are looking for. TÜV Rheinland can offer certification for products andquality management systems for medical device manufacturers doing business in the international marketplace.
Benefits
TÜV Rheinlands global presence means a quick return on investment
- One-stop shopping through a comprehensive range of services
- Customer satisfaction resulting in cost reduction
- TUVdotCOM certificate reference database
CE Certification of Medical Devices
- Active and non-active medical devices
- Active implantable medical devices
- In-vitro diagnostic medical devices
Comprehensive Service
- International approval of your medical devices
- EMC (Electromagnetic Compatibility)
- CB scheme for worldwide approvals
- Certification in accordance with EN ISO 13485 (and EN ISO 9001)
- Certification of QM systems for processing medical devices in risk categories up to and including C-critical
- GM Mark (approved medical device) for visible added value
- Medical aids
- TUVdotCOM Certificate reference database
