A Comprehensive Guide for Study Design, Notified Body Collaboration, Understanding Compliance Criteria and Using Best Practices for Execution Excellence.
Although majority of MedTech companies are aware of the EU-MDR and IVDR requirements pertaining to Labelling and Technical and Medical Device Master file, the new regulatory areas require a deeper understanding for conducting Post Authorization Safety Studies (PASS), Post-Marketing Surveillance (PMS) studies and Post-Market Clinical Follow-up Studies (PMCF).
This white paper primarily focuses on providing a comprehensive insight to medical device manufacturers for understanding PMCF study requirements, study conduct frequency for different classes of medical devices, completing PMCF study design, collaborating with Notified Bodies (NB) and Ethics Committees (EC) for study approval and adopting best practices for data management.