Risk Management - i.e. the planning, analysis and assessment of the risks related to a medical device is a requirement for premarket product approval in for example EU USA and Canada.
Through lectures and practical work with Risk Management of a product allow for thorough understanding and skills. Each participant will learn how to plan, lead, perform and report the results of Risk management activities.
Personnel in design, costruction, purchasing, production, engineering, QA and QC who will be involved in Risk Management.
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.
Course material is in English, presentation in English
6th Semptember 2018
DNV GL Busimess Assurance Czech Republic s.r.o., Thákurova 4, 1 60 00 Praque 6/ Hotel Diplomat
600,- € excluding VAT. DNV GL clients could apply 10% discount.
You can register on e-mail address: firstname.lastname@example.org or +420 603 575 839