Faster, smarter medical research. Schedule a demo In contrast with previous regulations, all Post-Market Clinical Follow-up (PMCF) clinical investigations will have to be conducted in compliance with the ISO 14155 standard. Read on to learn how this impacts medical device research. S. Derks The Impact of ISO 14155 on PMCF Investigations Under the MDR The regulatory landscape for clinical investigations with medical devices will significantly change with the adoption of the Medical Device Regulation (MDR) and the new version of ISO 14155. Faster, smarter medical research. Schedule a demo Executive Summary 3 Background 4 Quality Procedures 5 Clinical Investigation Plan Informed Consent Data Collection and Processing Data Monitoring and Document Management About Castor 6 7 8 9 10 casto

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