Program Overview

Quality and Regulatory Affairs for Medical Devices Industry

Overview

The Quality and Regulatory Affairs for Medical Devices Industry program is a specialized course designed to provide students with a comprehensive understanding of the quality management systems and regulatory affairs in the medical devices industry.

Objectives

The primary objectives of this program are to:

• Comprehend the concept of a Quality Management System and its key tools
• Understand the normative and regulatory environment of the medical devices industry
• Appreciate the regulatory requirements for placing a medical device on the market

Content

The program covers a range of topics, including:

• System of Quality Management: overview of industries and their quality management norms, key notions of quality management systems, and quality tools
• Case Study: Internal Quality Audit
• Regulatory Environment and Norms of the Medical Devices Industry: definition of a medical device, history of medical devices, market placement procedures, economic operators, clinical evaluation and investigations, applicable regulations and norms
• Exercises: Determination of general safety and performance requirements, analysis of vigilance examples
• Quality and Regulatory Affairs Functions in the Industry

Prerequisites

There are no prerequisites for this program.

Assessment

The knowledge assessment for this program consists of:

• Semester 9: The exam is only in English
• Session 1: 100% Multiple Choice Questions (MCQ)
• Session 2: 100% MCQ

Additional Information

This course is valued at 1.0 ECTS for students in the Transitions socio-ecological S9 MT curriculum and 2.0 ECTS for students in the Transitions socio-ecological S9 curriculum. The course is taught only in English in Semester 9.

Curriculum Integration

This course is part of several curricula, including:

• Cursus ingénieur->Apprentissage MEP->Semestre 9
• Cursus ingénieur->Double-Diplômes Ingénieur/Master->Semestre 9
• Cursus ingénieur->Filičre AM->Semestre 9
• Cursus ingénieur->Semestres A Choix->Semestre 9
• Cursus ingénieur->Cursus Internationaux->Semestre 9
• Cursus ingénieur->Masters->Semestre 9
• Cursus ingénieur->Filičre SEOC->Semestre 9
• Cursus ingénieur->Filičre EPEE->Semestre 9
• Cursus ingénieur->Filičre GEN->Semestre 9
• Cursus ingénieur->Apprentissage MT->Semestre 9
• Cursus ingénieur->Filičre IPhy->Semestre 9
• Cursus ingénieur->Cours transverses->Semestre 9
• Cursus ingénieur->Filičre SIM->Semestre 9
• Cursus ingénieur->Filičre SEI->Semestre 9
• Cursus ingénieur->Filičre BIOMED->Semestre 9
• Cursus ingénieur->Filičre SICOM->Semestre 9

Bibliography

• NF EN ISO 13485:2016
• MDR 2017/745
• 21 CFR part 820

Update

Last updated on 29/09/2025