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Regulatory Affairs
- FDA 510(k), PMA and IDE submissions
- Listing and registration with the FDA
- EU CE Mark activities for AIMD, MDD and IVD
- Liaison with FDA, Notified Bodies and Competent Authorities
- Submission and registration of products in the Far East, Oceania, Israel, South America and other non-EU countries.
- U.S. Agent services provided by our American subsidiary, MedicSense USA
- EU Authorized Representative services
- Development of product-related Regulatory Plans and Product Verification and Validation
- Implementation of technical aspects of both Standards and Testing as well as certification issues
- Investigation and reporting of incidents and adverse events
- Dedicated technical writing
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