Lecturer: Enrico Perfler  

Course name: Regulatory Affairs in medical device design, development and certification
Course code: 504860
Degree course: Bioingegneria, Computer Engeneering
Disciplinary field of science: ING-INF/06
University credits: ECTS 3
Course website: n.d.

Specific course objectives

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 Directives and to provide the main tools for managing medical device development and its certification.

Course programme

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

Course entry requirements

None

Course structure and teaching

Lectures (hours/year in lecture theatre): 23
Practical class (hours/year in lecture theatre): 0
Practicals / Workshops (hours/year in lecture theatre): 0

Suggested reading materials

Lecture notes provided by the teacher

Testing and exams

Written examination