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course med DNV Business Assurance
Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION
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About Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION Who can attend this course: - Managers and Personnel responsible for the CE certification of medical devices - Regulatory Affairs officer of certification evaluation for medical devices - Quality Assurance personnel responsible for device and system compliance - CE certification consultant of medical devices Course Objectives: This course enables you to understand the laws associated with the 2017/745 Medical Device Regulation and provides you with knowledge required for editing the technical documents for medical device manufacturers. This course pack is designed to help you; - Analyse of the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation) - Understand the structure of MDR - Understand essential requirements of MDR. - Gain knowledge about audit direction and process of Notified Body (NB) Course Leader: Anette Sjögren, PREVENTIA AB Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Language: Course material is in English. Presentation in English. Course agenda: Day 1: - Introduction of DNV - MDR overview and status of transition - MDD vs. MDR key changes - Scope of MDR & key definitions - General responsibility of manufacturers - Economic operator / UDI Day 2: - Conformity assessment module, DOC and sampling criteria - Classification rules - Technical documentation - GSPR (MDR) vs ERC (MDD) Day 3: - MDR clinical evaluation process - MDR Post Market Surveillance and PMCF - SSCP & PSUR - Vigilance - MDR Medical Device Quality Management System - QUIZ Are you looking for a customised course?: Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses. Please contact us for more information.
Foredragsholder: DNV Business Assurance
Sprog: Dansk
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