Number of hours
- Lectures 8.0
- Projects 0
- Tutorials 8.0
- Internship 0
- Laboratory works 0
- Written tests 0
ECTS
ECTS 2.0
Goal(s)
- Understand what a Quality Management System is and the main quality tools
- Understand the normative and regulatory environment of the industry
- Understand the regulatory requirements for the marketing of a medical device
Content(s)
Quality Management System
- Overview of some industry types and their QMS standards
- Main concepts :
Exercise: Process risk analysis - Some quality management tools
Exercise: Root cause Investigation and CPA
Case study: internal quality audit
The regulatory and normative environment for Medical Device Industry
- What is a Medical Device?
- Medical Devices History
- Procedures for placement on the market
- Economic operators
- Clinical evaluation and clinical investigations
- Applicable regulations and standards
Exercise: Determination of General safety and performance requirements - Design file, technical file
- Post market and vigilance requirements
Exercise: Vigilance example analysis - Country requirements for market authorizations and Registration (GUDID/Eudamed…)
Quality and regulatory affairs functions in the industry
Prerequisites
None
Test
- 1 case study
- 1 MCQ
Session 1 : 100% QCM
Session 2 : 100% QCM
Additional Information
This course brings 1.0 ECTS to students in Social-ecological transitions
Course list
Curriculum->Engineering degree->Semester 9
Curriculum->Double-Diploma Engineer/Master->Semester 9
Curriculum->Common courses->Semester 9
Curriculum->Apprentissage MEP->Semester 9
Curriculum->Semesters A Choice->Semester 9
Curriculum->Master->Semester 9
Curriculum->Internationals Cursus->Semester 9
Bibliography
NF EN ISO 13485 :2016
MDR 2017/745
21 CFR part 820