stage1 :BRINGING MEDICAL DEVICES TO MARKET
- Analysis of the normative and regulatory context of your developing projects
- Creation of CE marking applications (93.42.CEE & 98.79.CE) / 510K / other export applications
- FR/EU reimbursement application
Our experience means that we are able to help you to comply with the regulatory and normative requirements imposed by the various notified bodies
Our offerings
Renewal of CE marking / CE/510k modification application
Updating of DHFs / Product Files
Creation of specific documents: Clinical evaluation report (MEDDEV 2.7.1 Rev3)
Post-Marketing Surveillance Report, Critical Analysis Report (ANVISA), etc.
Introduction of new regulatory strategies: