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, 93/42/EEC, 93/42/EEC, 90/385EEC, 21CFR Part 11, ISO13485, 21CFR Part 11, 21CFR Part 11, 21CFR Part 11, ISO13485 Part 11, ISO13485, ISO42/EEC, 93/42/EEC, 93/42/EEC, 93/42/EEC, 90/385EEC, 21CFR Part 11, ISO13485, 21CFR Part 11, 21CFR Part 11, 21CFR Part 11, 21CFR Part 11, 21CFR Part 11, 21CFR Part 11, ISO13485, 21CFR Part 11, ISO13485, 21CFR Part 11, ISO13485, 21CFR Part 11, ISO13485, 21CFR Part 11, 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, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Design, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Risk Analysis, Design, Risk Analysis, Risk Analysis, Risk Analysis, Design, Risk Analysis, Risk Analysis, Design, Risk Analysis, Risk Analysis, Design, Risk Analysis, Risk Analysis, Design, Risk Analysis, Design, Risk Analysis
- 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
