Every manufacturer of medical devices is required to compile and keep up to date a technical documentation set, describing the product, its risk characteristics and its manufacturing process. Unitron Regulatory can help you building your technical documentation and meeting legislative obligations to be able to bring your medical device to the market.
From experience with many product dossiers, we thoroughly understand the European regulatory framework for active medical devices, the obligations set out for all key players in the device’s life cycle, and the challenges many parties face. If anything is unclear to you, or you are just looking for a second opinion, Unitron Regulatory offers advice.
Whether you are new to the industry or already experienced in this field, regulatory demands can be overwhelming. Regulation often states why and what, but as a manufacturer you need to know how. We know the how. And we want you to not feel alone.
Once on the market, a manufacturer is required to keep his product, its accompanying documents and technical documentation ‘state of the art’. One aspect of this is to keep complying with new standards, new revisions of standards and industry guidance. We offer support in this process in keeping you updated about changes regarding standards and regulation. In case of changes, we can perform gap analyses to assess the specific impact on your product. If documentation changes, design or manufacturing changes are necessary, our team can process these in close cooperation with our development and manufacturing departments.