The course is aimed at Quality Assurance personnel, Regulatory, Production and Research & Development of biomedical companies and legal medical device manufacturers of any class. The course describes the main methods for effective technology transfer of production processes. Level: Intermediate, it requires basic knowledge of the methodology IQ OQ PQ of process validation

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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: 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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Live Webinar: Drafting of the Biocompatibility report in accordance with ISO 10993-1 – 15 SEP 17 Duration: 50 min. + 10 min. Questions Time. Register Now! Download the Course Brochure   Description: ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based […]

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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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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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