Phelma Formation 2022

Quality and Regulatory affairs for Medical Devices industry (only for BIOMED and M2 NBS students) - 5PMCSMEB

  • 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
Contact Clara LABORIE

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