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: 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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Regulation 745/2017 on Medical Devices: Obligations of the economic operators, from Eudamed registration to Responsible person 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: definition of manufacturer, authorized representative, importer, distributor; […]

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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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Live Webinar Clinical Evaluation and literature data according to MEDDEV 2.7.1 rev June 2016 – May 29 Register Now! 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 main methods for writing an Evaluation […]

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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 structure and content of a technical file and its main attachments for the CE marking of a medical device. LEVEL: INTERMEDIATE (requires understanding of the current regulation)

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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 structure and content of a technical file and its main attachments for the CE marking of a medical device. LEVEL: INTERMEDIATE (requires understanding of the current regulation)

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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 structure and content of a technical file and its main attachments for the CE marking of a medical device. LEVEL: INTERMEDIATE (requires understanding of the current regulation)

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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 structure and content of a technical file and its main attachments for the CE marking of a medical device. LEVEL: INTERMEDIATE (requires understanding of the current regulation)

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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 structure and content of […]

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