E-ssentials MedDev Blog

Regulatory updates for the medical device industry

Class III: Design Dossier review in 3 steps

The requirements imposed on Design Dossiers of high-risk products (Class III) are very high. Reviews of Design Dossiers – and thus product certification – at the end of years of development do not always go as smoothly as anticipated. However, requirements have been specified so clearly that manufacturers can prepare in the best possible manner. To avoid delays for Class III products, TÜV SÜD offers a special procedure for Design Dossier review, accompanying you on every step towards successful approval.

Click here to read the details of our service model for the review of your Design Dossiers for Class III medical devices.

Dr. Bassil Akra

Dr. Bassil Akra

Vice President Global Focus Teams Cardiovascular, Orthopedic and Clinical

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