REF. MQ10 – INTRA / INTER
QUALITY SYSTEM
COURSE DESCRIPTION
This course will allow you to acquire practical knowledge to validate software applications in accordance with the requirements of ISO 13485:2016.
N.B. This course does not cover the validation of software considered to constitute Medical Devices or of software incorporated into Medical Devices.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand applicable normative requirements
- Understand the software application validation methodology
- Define and manage validation documents
- Apply the concepts learned to case studies
TARGET TRAINEES
Manufacturers of Medical Devices and subcontractors
PREREQUISITES
Familiarity with the requirements applicable to quality management systems (ISO 13485)
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- Group exercises
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Introduction
- Regulatory, normative and industrial context
- Software application validation principles
- Key principles
- Lifecycle approach
- Risk management
- Software application validation activities
- General information
- Validation process
- Documentation
- Validation of a software application – implementation
- Validation plan, risk management
- Documentation
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
