Regulatory, quality and clinical affairs
NX-451 / 2 credits
Teacher: Rochat Kim Julien
Language: English
Withdrawal: It is not allowed to withdraw from this subject after the registration deadline.
Summary
This regulatory, quality and clinical module aims at providing with the necessary tools and competences to apprehend the European regulatory framework for developing, validating and placing a medical device on the market, it defines the activities to be undertaken to comply with the applicable rules
Content
Regulatory approval (European & Swiss Medical Devices Regulation)
- Context of the European regulatory framework, introduction on the Medical Device Regulation (MDR), the In-Vitro Diagnostic Device regulation (IVDR), and the Swiss Law on Therapeutical Products. Concept of harmonized and technical standards, key operators on the market.
Medical Device Regulation: Introduction and Classification
- Keys regulatory expectations with medical devices, qualification and classification of a medical device.
Medical Device Development - Validation & Verification
- Development stages of a medical device, key activities and optimal sequence from the development to the marketing of a medical device. Introduction to verifications and validations
Risk Management of Medical Devices
- Presentation of Risk Management principles applied to medical devices, application of ISO 14971
Quality Management System ISO 13485:2016
- Presentation of Quality Management System, key activities and processes to consider, application of ISO 13485 requirements
Clinical Activities - Good Clinical Practices
- Key principles when designing and conducting a clinical investigation for a medical device, introduction to Good Clinical Practices
Introduction to Digital Health
- Particularities of Medical Devices Software, qualification of software as medical devices
Learning Outcomes
By the end of the course, the student must be able to:
- Interpret the regulatory context associated with medical devices in Europe
- Decide when medical device regulations are involved in a project
- Anticipate the constraints associated with the development and validation of medical devices
- Assess / Evaluate risks associated with medical devices
- Describe key process of a Quality Management System
- Plan key steps of a clinical trial
- Discuss opportunity and challenges of digital health
Transversal skills
- Use a work methodology appropriate to the task.
- Respect relevant legal guidelines and ethical codes for the profession.
- Access and evaluate appropriate sources of information.
Teaching methods
Presentation, lectures and use cases, individual and group study
Assessment methods
Use case evaluation, Multiple choices evaluation
In the programs
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Spring
- Exam form: During the semester (summer session)
- Subject examined: Regulatory, quality and clinical affairs
- Courses: 1 Hour(s) per week x 14 weeks
- Exercises: 1 Hour(s) per week x 14 weeks
- Type: optional
Reference week
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