Software validation for medical devices – Medical Devices (module 6) training in english / formation en français
- Know the regulatory and normative requirements with a focus on Europe and the USA
- Understand the elements of software life-cycle management
- Recognize why software development is different from developing mechanical devices
- Understand the expectations of Notified Bodies and Competent Authorities regarding documentation of software used in medical devices and software that is a medical device itself
Content / Topics addressed
- Why software validation ?
- Elements of software life-cycle management according to IEC 62304
- Software safety classes
- Primary processes : software development; software maintenance
- Secondary processes : documentation; testing/verification; problem resolution; configuration management and traceability analysis
- Software risk management : what is different regarding management of software risks; application of ISO 14971 and IEC 62366; IEC/TR 80002-1
- Practical examples
- Case studies and discussions
- Anybody in medical devices software development or using software aimed at supporting MD activities
Duration of training
- Working with software being used in a MD context
The dates for this training are not yet fixed. Do not hesitate to reserve your place without engagement if you are interested in this training.
Software validation for medical devices – Medical Devices (module 6)
Click to reserve
CHF 530.– (SAQ members)
Our prices include breaks, lunch and documents.
VAT not included on catering fees.
Mathias T Eng
Consultant, with many years of experience in providing professional services and advice to companies in the medical device, pharmaceutical, biotechnology, automotive and diagnostic industries. Specialist for Medical Device Software.