In a field that is characterized by fast-moving cycles of innovation, competence and quality are important factors for success. Place your trust in the experts at TÜV Rheinland. We are a notified body authorized to inspect your medical products and in vitro diagnostics and can assist you with the right conformity evaluation procedures for CE marks - meaning you can get your “driving license” for EU countries that little bit quicker. Upon request, we can also certify your quality management system in compliance with the EN ISO 13485, EN ISO 9001, or EN ISO 15378 norms.
With medical product audits and certification from TÜV Rheinland, you can:
As a manufacturer of medical products, the CE mark helps document the conformity of your products with the following directives:
Depending on the risk category of the product, you are required to commission a notified body to carry out an EG prototype audit, evaluation of a design dossier, or for auditing the quality management system. Together with you, we carry out the necessary conformity evaluation procedure for your products and company, meaning that you will receive your “driving license” for EU countries that bit quicker. On top of that, we can offer an audit of your medical products for specific or voluntary market requirements.
As a notified body, we carry out the following European homologation processes: