The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This part of course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.
Requirements on PMS has increased and are incorporated is in the ISO 13485:2016 and the new Medical Device Regulation. This course will give an introduction to the regulations and guidance on PMS (plan and report) as well as the process interfaces.
To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device. PMS process and its understanding, principles and continuity with other processes during whole life cycle of your medical device(s).
Clinical QA/RA specialists, risk managers, management, design&development engineers, customer support/service and marketing.
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
25-26 th April 2019
DNV GL Busimess Assurance Czech Republic s.r.o., Thákurova 4, 1 60 00 Praque 6/ Hotel Diplomat
1000,- € excluding VAT. DNV GL clients could apply 10% discount.
You can register on e-mail address: email@example.com or +420 737 212 732