Regulation 745/2017 on Medical Devices: Unique Device Identification number requirements Duration: 1 hour Prerequisite: basic knowledge of medical devices and regulatory requirements in Europe Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Importers Distributors of medical devices in Europe and their suppliers Contents: unique identification number composition; where and how it is placed; […]

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Regulation 745/2017 on Medical Devices: technical file structure Duration: 1 hours Prerequisite: basic knowledge of medical devices and regulatory requirements in Europe Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers Contents: Annex I and Annex II of MDR; main contents expected in the technical […]

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Regulation 745/2017 on Medical Devices: post market activities and follow up Duration: 1 hour Prerequisite: basic knowledge of medical devices Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers Contents: Required updates of Technical File over time; methods for post market follow up according to […]

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The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes how to present the technical data of products to the Ethics Committees for authorization to perform clinical investigations on human patients. LEVEL: INTERMEDIATE (requires understanding of the […]

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Regulation 745/2017 on Medical Devices: main changes and timeline to implementation Duration: 1 hour Prerequisite: basic knowledge of medical devices Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers Contents: The Commission position on medical devices; regulation implementation timeline, main impacts on existing devices, main […]

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The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the main methods for writing an Evaluation Report of the Clinical Evaluation to be included in the product Technical dossier according to the new MEDDEV 2.7.1 guideline Rev June 2016. […]

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Live Webinar – Regulation 745/2017 on Medical Devices – 5 Lessons – 8 Hours Register Now! Description: Prerequisite: basic knowledge of medical devices Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers   Complete learning program: 09 Jun – Regulation 745/2017 on Medical Devices: main […]

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Live Webinar – Technical File Structure according to New Medical Device Regulation Register Now! Duration: 50 min. + 10 min. Questions Time. Description: The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the methods of Unique Device […]

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NEW EU Medical Device Regulations 2016-Live Webinar  Register Now! Download the course Brochure  Duration: 50 min. + 10 min. Questions Time. ON DEMAND: Fill the form below to schedule the live webinar on demand session: Description: This live webinar course will provide guidance on the new requirement introduced with NEW EU Medical Device Regulation. In Particular will […]

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