Software validation for medical devices – Dispositifs médicaux module 11 11 January 2019 Yverdon-les-Bains
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- 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
|11 January 2019
Software validation for medical devices – Dispositifs médicaux module 11
CHF 520.– (SAQ members)
Our prices include breaks, lunch and documents.
VAT not included on catering fees.
Mathias T Eng
Consultant, with 15 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.