Software validation for medical devices – Dispositifs médicaux module 6  le 26 avril 2019  Yverdon-les-Bains

Objectifs

• 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

Contenu / Thèmes abordés

• 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

Pédagogie

• Lecture
• Practical examples
• Case studies and discussions

Public cible

• Anybody in medical devices software development or using software aimed at supporting MD activities

Durée de la formation

• 1.0 jour

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Prérequis

• Working with software being used in a MD context

Date

Yverdon-les-Bains
Formation
26 avril 2019

Software validation for medical devices – Dispositifs médicaux module 6

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