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Post-Market Surveillance (PMS) for Medical Devices
Post-Market Surveillance (PMS) for Medical Devices
- Development of PMS strategy for the device based on risk profile.
Medical Device Authorized Representative
Medical Device Authorized Representative
- Single point of contact in the country for liaison with Health Authorities (HAs)
US FDA Agent Service
US FDA Agent Service
- As your U.S. Agent, Freyr serves as a liaison between your company and the FDA
European Authorized Representative (EC REP) Services
European Authorized Representative
Medical Device Literature Search Protocol and Review
Frequently Asked Questions (FAQs)
01. What is the purpose of a medical device literature search protocol under EU MDR/IVDR?
Medical Device Lifecycle Management
In Vitro Diagnostics (IVD) and Medical Device Lifecycle Management
Periodic Safety Update Report (PSUR) for Medical Devices
Periodic Safety Update Report
- Development of PMS strategy for the device based on risk profile.