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.
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.
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
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.
Course material is in English, presentation in English
Is needed: internet connection, laptop or PC, Online Seminar: „GoToTraining“ application
Note: Slovak VAT will be applied for all participants.