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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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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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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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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