Principal Consultant NAMSA Brummen, Gelderland, Netherlands
Please note that a separate fee is required to attend this pre-conference workshop and is not included in the main registration for the 2021 Euro Convergence. If you have already registered for the conference and would like to add this workshop, please contact email@example.com or log in to the registration system and modify your registration. Registration for preconference workshops closes on 5 May at 23:59 CEST. CLICK HERE TO REGISTER
With the imminent approach of the Date of Application of the Medical Device Regulation (MDR), companies that place Medtech products on the EU market need to know how to meet the MDR Post-Market Reporting requirements, specifically the new requirements under Article 88/Trending and Periodic Safety Update Reporting (PSUR). These new reporting requirements will not only consume more time and resources than ever before, it specifically requires good understanding how to effectively and efficiently comply with these requirements. This workshop will provide a detailed overview of the Trending and PSUR requirements as well as practical guidance how to approach compliance with these requirements.
MDR Post-Market Reporting requirements
Article 88/Trending and statistical approaches to effective and efficient Trending
Guidance to PSUR data input and information output