How can we help?
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 IVD in the EEA.
The transition from the IVDD to the IVDR poses strenuous demands on manufacturers. In order to be compliant with the IVDR requirements, manufacturers will need to re-classify their IVDs, 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 can help ease the transition process for your company and arrange the required testing for your IVD products.
We additionally offer our services as the Person Responsible for Regulatory Compliance (PRRC), a new requirement set by the IVDR to ensure regulatory compliance.