5PMCBRE1 : Business regulation - WPMCDSMB

Goal(s)

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

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

None