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Our engineering & Master degrees
Our engineering & Master degrees

> Studies

5PMCSMER : Regulation of business - WPMCDSMR

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  • Number of hours

    • Lectures : 8.0
    • Tutorials : 8.0
    • Laboratory works : 0
    • Projects : 0
    • Internship : 0
    • Written tests : 0
    ECTS : 1.5

Goals

Contact Jean Christophe KLEIN

Content

1- Regulatory context 1h
a. History of medical devices regulation
b. Why a module on regulatory affairs
c. Health industry : A regulated industry

2- Quality management 4h
a. Quality management system
b. ISO 13485
c. Design control requirements
d. Product quality (standards)

3- CE marking for Medical devices
a. Medical Device Directive 4h
i. Regulatory bodies and other stakeholders : notified bodies, competent authorities, working groups
ii. CE marking : different pathways, cots, requirements, submission scheme…
iii. Technical file/Design Dossier content
iv. Change control

b. In Vitro medical Device Directive 4h
i. IVD CE marking pathway
ii. Technical file/Design Dossier content
iii. Focus on IVD/MD differences
iv. Change control

4- US and other regions 1h
5- Practical case 2h



Prerequisites

AUCUN

Tests

CONTRÔLE CONTINU



Additional Information

Curriculum->MASTER PHYSIQUE MATENG->Semester 10
Curriculum->Master->Semester 10
Curriculum->Double Diploma GEN-EN->Semester 10
Curriculum->Double-Diploma Engineer/Master->Semester 10
Curriculum->MASTER PHYSICS / NUCLEAR ENERGY->Semester 10

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Date of update October 21, 2019

Université Grenoble Alpes