Having an own Regulatory Affairs Department, GEMÜ is able to help the customer meet national and international regulatory requirements in the early stages of product development. Thus, you can rest assured that your product complies with the latest regulatory requirements.
Our certified validation processes provide documented verification that the production of your medical technology product is reliably and permanently guaranteed.
Normative and regulatory basis
With the help of our network of partners we would also be pleased to help you in the following areas:
The process for the optimal cleanroom product
At GEMÜ, projects comprise five phases. The end of each phase represents a milestone; it contains a review as well as the release for the next phase. Customer solutions primarily begin in phase three. If necessary GEMÜ can assist you during phases 1 and 2.
GEMÜ Medical promotes innovation with verified market expertise.
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