REGULATORY AFFAIRS IN DESIGN, PRODUCTION AND CERTIFICATION OF MEDICAL DEVICES
Stampa
Enrollment year
2019/2020
Academic year
2020/2021
Regulations
DM270
Academic discipline
ING-INF/06 (ELECTRONIC AND INFORMATION BIOENGINEERING)
Department
DEPARTMENT OF ELECTRICAL,COMPUTER AND BIOMEDICAL ENGINEERING
Course
COMPUTER ENGINEERING
Curriculum
PERCORSO COMUNE
Year of study
Period
2nd semester (08/03/2021 - 14/06/2021)
ECTS
3
Lesson hours
23 lesson hours
Language
Italian
Activity type
WRITTEN AND ORAL TEST
Teacher
PERFLER ENRICO (titolare) - 2 ECTS
OLIVERI IVANO - 1 ECTS
Prerequisites
None
Learning outcomes
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 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
Teaching methods
Lectures
Reccomended or required readings
Regulation EU 2017/745 and amendments, documents shared by professor, slides commented during the lessons
Assessment methods
Written exam
Further information
None
Sustainable development goals - Agenda 2030