DNV GL Danmark

Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION

Medical_Device_Regulation

Revisions of EU medical device regulation is being planned from 2020. This course enables to understand the new laws with the 2017/745 Medical Device Regulation and provides knowledge requirements for the editing technical document for medical device manufacturers.

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

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.

Program:

The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.

Day 1:

- 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.

Day 2:

- Understanding the structure of MDR

- Essential requirements of MDR

- Classification / conformity route

- Risk management of MDR

Day 3:

- Clinical judgment of MDR

- MDR PMS/PMCF

- Understanding editing Process of technical documentation

- QUIZ

Venue:

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.

Kontakt os for yderligere information

Do you have any questions?

Contact us

Register for the training class here

REGISTER

Hvornår:

24. november - 26. november 2020

Add to calendar 2020/11/24 09:00 2020/11/26 18:00 Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION Revisions of EU medical device regulation is being planned from 2020. This course enables to understand the new laws with the 2017/745 Medical Device Regulation and provides knowledge requirements for the editing technical document for medical device manufacturers.
https://www.dnvgl.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.
false YYYY/MM/DD akeGphYOczrmtQTfhmEQ22349

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:

- 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

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.

Program:

The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.

Day 1:

- 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.

Day 2:

- Understanding the structure of MDR

- Essential requirements of MDR

- Classification / conformity route

- Risk management of MDR

Day 3:

- Clinical judgment of MDR

- MDR PMS/PMCF

- Understanding editing Process of technical documentation

- QUIZ

Venue:

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.

Interne kurser for din virksomhed

Kontakt os