About Medical Device Regulation
To give a good introduction of the MDR as preparation of what is coming soon.
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support and marketing, distributors, importers and authorized representatives 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.
Course material is in English.
Presentation in English or Swedish (depending on the participants).
The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.
Chapters I – IV with relevant appendices and guidance along, exercises and workshops within definition, technical documentation.
Chapters V -VII with relevant appendices and guidance along, exercises and workshops within classification, labelling and PMS.
The training is held in the area of Copenhagen, Denmark