Buyers, users, and consumers all want the same thing: medical devices that offer a high standard of quality and safety. That's why we developed the "Tested Medical Device" label, our GM mark. This test mark goes above and beyond the standard legal requirements. It includes additional tests, such as a product site inspection and a technical documentation review. Use our GM mark to ensure confidence in your products.
With TÜV Rheinland's independent test mark, you can:
Our experts certify your medical devices in three steps:
We test your product at our site and review your technical documentation.
2. Site Inspection
We inspect your production facility.
3. Quality Seal
If the certification is successful, you receive a certificate from us.
The "Tested Medical Device" quality mark is issued for medical devices that meet the following criteria:
1. Legal requirements:
2. Further criteria that go beyond legal requirements: