MDPharmaCourses | Regulatory, Quality and Compliance Training

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 changes and timeline to implementation  16 Jun – Regulation 745/2017 on Medical Devices: obligations of the…

MDPharmaCourses | Regulatory, Quality and Compliance Training

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 Identification (UDI) and traceability of products for the CE marking and its main aspects as in…

MDPharmaCourses | Regulatory, Quality and Compliance Training

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 discuss the following points: Main New Requirements (UDI) Unique Identification number Post market activities New Technical…

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ISO 13485:2016 – Transition Training – Recorded Live Webinar Register Now! Download the Brochure This recorded live webinar course will provide guidance on how to perform the transition to the Medical Device Quality Management System (QMS) Standard ISO 13485:2016. In Particular will discuss the following points: 1. Comparison with previous version of ISO 13485 2. Impact on existing QMS 3. Consistency with new ISO 9001:2015 4. Regulatory impact The new ISO 13485:2016 standard…

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