Medical Innovation Exchange

post-market surveillance

Role of Clinical Evaluation Report Consultants

Role of Clinical Evaluation Report Consultants     In the dynamic landscape of medical device regulations, ensuring the safety and efficacy of healthcare products is of utmost importance. One of the critical aspects of this process is the clinical evaluation of medical devices. A well-written Clinical Evaluation Report (CER) is vital for demonstrating the device’s safety …

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UK Releases Draft Post Market Surveillance Requirements for Medical Devices

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

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

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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