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 and marketing, distributors, importers and authorized representatives 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).
Program:
The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.
Day 1:
Introduction MDR
Chapters I – IV with relevant appendices and guidance along, exercises and workshops within definition, technical documentation.
Day 2:
Chapters V -VII with relevant appendices and guidance along, exercises and workshops within classification, labelling and PMS.
Examination
Venue:
The training is held in the area of Copenhagen, Denmark