Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION
The revised Medical Device Regulation (2017/745) entered into Force in 2017 and has date of application May 26, 2021. This course provides a knowledge of the requirements of the regulations including the requirements for Technical Documentation and Quality system requirements.
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.
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.