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UK Releases Draft Post Market Surveillance Requirements for Medical Devices

Leave a Comment / complaint management, Great Britain, incident response plan, Medical Device, MedTech, post-market surveillance, Quality/Regulatory, RC - EU MDR and IVDR, RC - Medtech Regulatory Resource Center / By

UK Releases Draft Post Market Surveillance Requirements for Medical Devices     The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” are approved, they will pertain to devices sold in England, Wales, Scotland and …

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Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market

Leave a Comment / AI, complaint management, EU MDR, Focus Article, From The Editor's Desk, Medical Device, medical device regulation, MedTech, post-market surveillance, Quality/Regulatory, RC - Quality & Regulatory Market Access Solutions, systematic literature reviews / By

Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market     Global regulatory demands for medical devices are increasing substantially, and regulatory teams are faced with the pressure of increased workloads and the need for more resources. To help regulatory professionals identify strategies and best practices in developing an effective and sustainable regulatory strategy …

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FDA Seeks Industry Collaboration on Medical Device Active Surveillance System

Leave a Comment / data caprtue, Medical Device, medical device active surveillance, MedTech, post-market surveillance, Quality/Regulatory, RC - Quality & Regulatory Market Access Solutions, safety signals / By

FDA Seeks Industry Collaboration on Medical Device Active Surveillance System     The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system. “Once realized, such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess …

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