The medical device technology is characterized by an high turnover (it is estimated that each superseding improvement usually arrives within 18-24 months). Therefore, to be competitive, manufacturers must continue to innovate by researching and developing new technical solutions, new materials and safer and more effective treatments. In this dynamic and competitive environment, patient timely access to the latest effective and safe diagnostic and therapeuthic procedures is counterbalanced by the necessity of ensuring that new medical device technologies are safe and do not represent a risk for public health. The intent of this course is to give an introduction to the regulatory affairs fundamentals, to analyse the European Medical Device Regulations and to provide the main tools for managing medical device development and its certification.
Course Prerequisites
None
Teaching Methods
Lectures
Assessment Methods
Written exam
Texts
Regulation EU 2017/745 and amendments, documents shared by professor, slides commented during the lessons
Contents
Regulatory Affairs and Quality Assurance The role of the "Regulatory Affairs" manager EU Directives in the medical device sector Harmonized standards and international technical standards The role of Notified Bodies and National Competent Authorities Design and development of a medical device A new medical device: clinical need, technical feasibility, costs, market opportunities Design and development of a new medical device in compliance to applicable directives Design control (design, verification and validation of a medical device) Company certification and CE marking ISO 13485 Company certification plan and quality management system Preparation of a medical device Technical File and CE-marking
