DNVGL.com

MDR - Medical device regulation Online Seminar (in English)

Healthcare certification

A two-day course on the Medical Device Regulation, which will replace the Medical Device Directive.

Background:

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 has been 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.

Scope:

To give a good introduction of the MDR as preparation of what is coming. What kind of requirements will increased, changed and what preparation  is neccessary for transition and need to be start as soon as possible.

Intended for:

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. The knowledge and her learning from standardization work will also play an important part in the courses.

Language:

Course material is in English, presentation in English

Time:

29th-30th September 2020. The exact timetable will be specified.

Place:

Online Seminar: „GoToTraining“ application

Is needed: internet connection, laptop or PC, Online Seminar: „GoToTraining“ application

Price:

850,- € excluding VAT. DNV GL clients could apply 10% discount

Note: Czech VAT will be applied for all participants.

 

Background:

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 has been 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.

Scope:

To give a good introduction of the MDR as preparation of what is coming. What kind of requirements will increased, changed and what preparation  is neccessary for transition and need to be start as soon as possible.

Intended for:

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. The knowledge and her learning from standardization work will also play an important part in the courses.

Language:

Course material is in English, presentation in English

Time:

29th-30th September 2020. The exact timetable will be specified.

Place:

Online Seminar: „GoToTraining“ application

Is needed: internet connection, laptop or PC, Online Seminar: „GoToTraining“ application

Price:

850,- € excluding VAT. DNV GL clients could apply 10% discount

Note: Czech VAT will be applied for all participants.

 

Link to Legislation:

The Medical Devices Directive 93/42/EEC