TUV USA is a well-established, and reliable partner, for medical device certification services globally. Our experts and auditors have extensive knowledge and guarantee independence and neutrality. We offer a variety of medical standards including: ISO 13485:2016, MDD 93/42/EEC, and EN ISO 13485:2016. The head office in Germany, TÜV NORD Cert., is handling the recognition process for MDR. Furthermore, as of September 5, 2018, we are proud to announce that TUV USA became one of the few Certification Bodies to receive full recognition as a Recognized Auditing Organization under the MDSAP Program.
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