DNV GL Danmark

Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION

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 GL

- 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.

Kontakt os for yderligere information

Do you have any questions?

Contact us

Register for the training class here

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Hvornår:

Add to calendar 2021/09/14 09:00 2021/09/16 18:00 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.
https://www.dnv.dk/training/introduction-to-mdr-eu-2017-745-medical-device-regulation-156023
This only adds the event to your calendar, please remember to register for this event.
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Varighed:

The training is held online. Duration: 3 days

Pris:

Course fee: DKK 17.900,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

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 GL

- 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.

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