DNV GL Danmark

Medical Device Regulation

Medical_Device_Regulation

The medical device directive (MDD) has been in force since 1996 and it is mandatory to comply with it to CE mark products in the EU. There was an amendment in 2007 (2007/47/EC) and today there are new regulations on their way to replace the directive – the MDR. The new regulation is based on the MDD, the guidance documents to the MDD (MEDDEV) and also some new and changed parts are coming.

About Medical Device Regulation

Goal:

To give a good introduction of the MDR as preparation of what is coming soon.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

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 or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

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When:

Add to calendar 2020/03/03 09:00 2020/03/04 18:00 Medical Device Regulation The medical device directive (MDD) has been in force since 1996 and it is mandatory to comply with it to CE mark products in the EU. There was an amendment in 2007 (2007/47/EC) and today there are new regulations on their way to replace the directive – the MDR. The new regulation is based on the MDD, the guidance documents to the MDD (MEDDEV) and also some new and changed parts are coming.
https://www.dnvgl.dk/training/medical-device-regulation-156023
This only adds the event to your calendar, please remember to register for this event.
Copenhagen, Denmark false YYYY/MM/DD akeGphYOczrmtQTfhmEQ22349

Available dates and venues

Varighed:

Duration: 2 days

Pris:

Course fee: DKK 12.500,- (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 Medical Device Regulation

Goal:

To give a good introduction of the MDR as preparation of what is coming soon.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

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 or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

Available dates and venues

DATES VENUE REGISTER BY COURSE FEE ADDITIONAL INFORMATION
DATES
3. marts - 4. marts 2020
VENUE
Copenhagen, Denmark
REGISTER BY
COURSE FEE
ADDITIONAL INFORMATION
DATES
15. september - 16. september 2020
VENUE
Copenhagen, Denmark
REGISTER BY
COURSE FEE
ADDITIONAL INFORMATION

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