Content and structure
– The regulatory framework for medical devices
– Standards and European guidelines
– Clinical evaluation – verification of safety and performance through clinical data
– Clinical evaluation – methodological aspects
– The regulatory framework for clinical evaluation and clinical trials of medical devices
– Statistics
– Risk management – analyzing, assessing and controlling risks
– ISO 14155 – GCP for medical devices
– The clinical evaluation report
Participants
Emma Larsson, Gothia Forum
Ann-Catrin Petersson, Mölnlycke Health Care
Ulf Ellerfelt, Nordic Regulatory Consultants
Karl-Gustaf Strid, K-G Strid AB
Mikael Åström, ERC Syd/ Region Skåne
