Enterprises purchasing class 3 medical devices need to ask the supplier what qualifications?

Hello, this depends on which aspect of the medical device products you buy, different products require qualifications are not the same, Class 3 medical device products, in the medical device is the highest level of products, the general supplier will do the ISO13485 certification, you can for you to buy the medical device products, our customers will suggest that he let the supplier to provide "Biocompatibility test report"

Shenzhen Tenglian enterprise consultant to provide you with:

1. Medical device product registration (for the record)

2. Medical device production license (for the record)

3. Medical device business license (for the record)

4. ISO13485 quality management system establishment

5. Radiation safety license

6. CE certification

7. FDA registration, etc.

One-stop medical device technical services~

Watch out for the adoption of, thank you