Benefit from our experience in creating regulatory compliant clinical evaluations. For advancements of existing medical devices as well as for new and innovative medical devices, which are based on existing medical and technical procedures, PROSYSTEM will check for you the possibility to perform the clinical evaluation on the literature route. Also profit from our expertise when updating your clinical evaluation. As a matter of course, we will check your already existing clinical evaluation with respect to regulatory compliance.
Our quality management system is certified according to ISO 9001. Our procedures warrant that the principles of the MEDDEV 2.7.1 guideline are considered when creating or updating your clinical evaluation. In the same manner, we create standard operating procedures and templates – customized to the individual needs of your company – which prepare you optimally for audits through your notified body.
Overall, our experienced clinical authors will support you, offering the following services:
- Creating and updating clinical evaluation reports according to MEDDEV 2.7.1
- Route of the clinical evaluation: Will the literature route be sufficient or will you need to generate clinical data within the scope of a clinical investigation?
- Which marketing claims may be used?
- Conduct of literature reviews
- Database research of clinical experience data
- Creation of standard operating procedures and templates
- Training of your colleagues