Preparing the CE dossier could be a cumbersome process as it involves many different documents, templates, reports, and charts reflecting at least as many intricate processes and decision maps. GEMARMED’s experts are well versed in the practice of CE dossier compilation and can guide you through the process or assist in preparing all pertinent documentation, ensuring a successful registration of your device in the EEA. GEMARMED maintains long-standing relationships with various Notified Bodies. We are familiar with their specializations and are able to direct our clients to the Notified Body most appropriate for their products.
The transition from the MDD to the MDR poses strenuous demands on manufacturers. In order to be compliant with the MDR requirements, manufacturers will need to assess their Quality Management System and the technical documentation of their products and close any gaps. Conducting this gap analysis can be time consuming and costly. GEMARMED’s experts have years of experience navigating the ever-changing international regulatory medical device environment and can help ease the transition process for your company.
We additionally offer our services as the Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person, a new requirement set by the MDR to ensure regulatory compliance