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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

Business regulation - 5PMCSMEB

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  • Number of hours

    • Lectures : 8.0
    • Tutorials : 8.0
    • Laboratory works : 0
    • Projects : 0
    • Internship : 0
    • Written tests : 0
    ECTS : 2.0

Goals

Understand the challenges of the regulatory context, maintaining compliance and quality control
Know the normative standards applicable in MD and DMDIV (medical devices for in vitro diagnostics)
Recognize a DM / DMDIV
Understand the impact of normative standards throughout the life of the product, in particular on the product design phase
Understand the conformity and quality assessment procedures of MD / DMDIV
Know the actors involved in the assessment of product conformity throughout the life of the product
Be autonomous in the search for applicable normative standards

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

None

Tests

Continuous control



Additional Information

Curriculum->Internationals Cursus->Semester 9
Curriculum->Common courses->Semester 9
Curriculum->Semesters A Choice->Semester 9
Curriculum->Master->Semester 9
Curriculum->Double-Diploma Engineer/Master->Semester 9
Curriculum->Engineering degree->Semester 9

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Université Grenoble Alpes