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School of engineering in Physics, Applied Physics, Electronics & Materials
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Our engineering & Master degrees
Our engineering & Master degrees

> Studies

- 5PMCSMER

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  • Number of hours

    • Lectures : 8.0
    • Tutorials : 8.0
    • Laboratory works : ?
    • Projects : ?
    • Internship : ?
    • Written tests : ?
    ECTS : 2.0

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

This course brings 1.5 ECTS to students in UE SME (S6-WICS)

Curriculum->Master TSI SIGMA->Semester 9
Curriculum->EPEE->Semester 9
Curriculum->Semesters A Choice->Semester 9
Curriculum->MASTER PHYSIQUE MATENG->Semester 9
Curriculum->GEN->Semester 9
Curriculum->Master->Semester 9
Curriculum->Internationals Cursus->Semester 9
Curriculum->SEI->Semester 9
Curriculum->IPhy->Semester 9
Curriculum->Double-Diploma Engineer/Master->Semester 9
Curriculum->Common courses->Semester 9
Curriculum->Master RI AMIS->Semester 9
Curriculum->Master RI EFM->Semester 9
Curriculum->SICOM->Semester 9
Curriculum->FSC-MAN->Semester 9
Curriculum->SIM->Semester 9
Curriculum->Master EEA WICS->Semester 9
Curriculum->Master RI FAME->Semester 9
Curriculum->Master RI MANUEN->Semester 9
Curriculum->Master PhSem->Semester 9
Curriculum->Degree Advanced Materials (AM)->Semester 9
Curriculum->MASTER IN / NUCLEAR ENERGY->Semester 9
Curriculum->BIOMED->Semester 9

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Date of update March 19, 2019

Grenoble INP Institut d'ingénierie Univ. Grenoble Alpes