Phelma Formation 2022

Regulation of business - 5PMCSMER

  • 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)

Contact Jean Christophe KLEIN

Content(s)

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

Test

CONTRÔLE CONTINU



Additional Information

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

Course list
Curriculum->EPEE->Semester 9
Curriculum->Master->Semester 9
Curriculum->Internationals Cursus->Semester 9
Curriculum->IPhy->Semester 9
Curriculum->Double-Diploma Engineer/Master->Semester 9
Curriculum->Master RI AMIS->Semester 9
Curriculum->Double-Diploma IPhy-UGA->Semester 9
Curriculum->Double-Diploma SEI-EEA WICS->Semester 9
Curriculum->SIM->Semester 9
Curriculum->Double Diploma BIOMED - N2BIO->Semester 9
Curriculum->Master RI FAME->Semester 9
Curriculum->Double Diploma EPEE - ELECTROCH->Semester 9
Curriculum->BIOMED->Semester 9
Curriculum->Master TSI SIGMA->Semester 9
Curriculum->Semesters A Choice->Semester 9
Curriculum->GEN->Semester 9
Curriculum->Double-Diploma SICOM-TSI SIGMA->Semester 9
Curriculum->SEI->Semester 9
Curriculum->Common courses->Semester 9
Curriculum->Master RI EFM->Semester 9
Curriculum->Double Diploma BIOMED - Structural->Semester 9
Curriculum->Double-Diploma IPhy-PhSem->Semester 9
Curriculum->SICOM->Semester 9
Curriculum->FSC-MAN->Semester 9
Curriculum->Double Diploma GEN-EN->Semester 9
Curriculum->Master RI MANUEN->Semester 9
Curriculum->Degree Advanced Materials (AM)->Semester 9