1 day
680
€ H.T including breaks and lunch
Objectives of the internship
- Know and understand the requirements applicable for the GxP regulatory compliance of computerized medical devices and for the computerized systems involved in the quality of medical devices.
- Acquire the methodological principles recommended by Regulatory bodies for GxP compliance (CE, FDA) of computerized medical device systems.
- Know and understand the differences between CE requirements and FDA requirements for computerized medical devices and for computerized medical device accessories.
Teaching methods
- Course based on the guidelines of the FDA (Part 11), NB-MED and G-MED, NB-MED and G-MED, ISO14971, iec62304, ISO/TR 80002-2
- Concrete case studies
- Work in sub-groups
- Presentation and delivery of a summary document
Staff concerned
Production Department, IT Department, Quality Assurance and Validation
Detailed program
1 — REMINDER OF THE EUROPEAN AND AMERICAN REGULATORY ENVIRONMENT
- Applicable directives: 98/79/EC, 93/42/EEC, 93/42/EEC, 90/385EEC, 90/385EEC, 90/385CEE, 21CFR, 21CFR Part 11, ISO13485, ISO14971, ISO14971, IEC 62304, IEC 62304, ISO/TR 80002-2
- Applicable recommendations and guides: NB-Med/2.2/Rec4, FDA General principles of software validation for medical devices, GAMP5
- Organizations: G-MED, ANSM, FDA
- Key points of specific software requirements
2 — METHOD FOR DETERMINING THE APPLICABILITY OF FDA REQUIREMENTS AND CE MARKING OF SOFTWARE
- Software classification according to the CE Mark and the standards IEC 62304 and ISO/TR 80002-2
- Good Practices specific to software according to GAMP 5, standards IEC 62304 and ISO/TR 80002-2, 21 CFR Part 11: Quality process to control the software life cycle, Risk Analysis approach, Risk Analysis, Design, Design, Validation, Maintenance
- Risks specific to software identified and monitored during inspections
3 — PROVEN SOFTWARE VALIDATION METHOD ACCORDING TO GAMP5
- Principles, tasks and activities
- Specifications: user, functional and design
- Risk analysis based on ISO14971
- Qualification, verifications, Tests
- Maintenance, change management, security and operational continuity
4 — DIFFERENCES BETWEEN EU REQUIREMENTS AND FDA REQUIREMENTS
