About Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION
Who can attend this course:
- Head of the department responsible for the CE certification evaluation of medical devices
- Regulatory Affairs officer of certification evaluation for medical devices
- Response Officer of CE certification evaluation for medical devices
- CE certification consultant of medical devices
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)
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.
Course material is in English.
Presentation in English.
The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.
- Introduction of MDR
- Background of MDR revision
- MDR VS MDD
- Status of certification institution according to the MDR revision
- Information of the direction of the evaluation and the change of the audit process of other certification institution according to the MDR revision.
- Understanding the structure of MDR
- Essential requirements of MDR
- Classification / conformity route
- Risk management of MDR
- Clinical judgment of MDR
- MDR PMS/PMCF
- Understanding editing Process of technical documentation
The training is held as online training
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.