After your product has been CE-marked you are required by the Medical Device Directives to watch over the quality of your product and make sure that it always fulfils the most recent applicable standards and technological developments.
The Notified Body will regularly carry out audits to evaluate the product conformity. Moreover, the Competent Authorities may ask for assessment of the CE Master File and for additional clarifications. You can always count on BioTop Medical assistance in every of these situations:
- We coordinate the regular revision of your CE Master Files;
- We keep you up-to-date on the development of standards applicable to your product;
- We help you with Vigilance Cases;
- We help you with the Post Marketing Surveillance Plan and Report.
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