MDR - Medical device regulation (in English)
A two-day course on the forthcoming Medical Device Regulation, which will should replace the Medical Device Directive.
Background
The medical device directivr (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 changeg parts are coming.
Scope
To give a good introduction of the MDR as preparation of what is coming soon. 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) commitee and was also part of the international PMS task force. The knowledge and her learning from standardization work will also pa an importnat part in the course.
Language:
Course material is in English, presentation in English
Note: Czech VAT will be applied for all participants.
Background
The medical device directivr (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 changeg parts are coming.
Scope
To give a good introduction of the MDR as preparation of what is coming soon. 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) commitee and was also part of the international PMS task force. The knowledge and her learning from standardization work will also pa an importnat part in the course.
Language:
Course material is in English, presentation in English
Note: Czech VAT will be applied for all participants.