Technical Training

Software Risk Management (Medical Device & Digital Therapeutics Software)

Objectives

The role of software in medical devices has grown enormously over the years. With this growth, the effort of establishing the safety and effectiveness of SiMD (Software in a medical device) and SaMD (Software as a medical device) has become more significant and more challenging.

This immersive 3-day programme on Software Risk Management for Medical Device and Digital Therapeutics Software follows the ISO 14971 process model and focuses on IEC 62304 and IEC/TR 80002-1 for insight into software risk management activities and documentation. The course promotes integration of software risk management into each activity of the software development lifecycle (SDLC) and creation of safety awareness among the entire product development organisation. Other standards utilised during the 3-day course include IEC 82304, IEC 62366, cybersecurity (AAMI TIR 57, emerging IEC 81001-5-1), and upcoming IEC 62304 2nd edition impact to risk.

Content includes

This immersive 3-day virtual course consists of eight core modules:

• Pertinent Regulations & Standards
• Process Overview
• Intended Use & Device Risk
• Software Hazards Analysis
• Risk Evaluation
• Risk Control
• Residual Risk Benefit Analysis
• Post Market Risk Analysis Re-Evaluation

Each module is delivered through instruction, Q&A, individual and group exercises, and discussion of real world examples.

Learning Outcomes

Delegates will come away fully confident in how to perform software risk analysis and understand the concepts of ISO 14971, IEC 8002-1, and the software risk management requirements of IEC 62304.

Upcoming dates:

No training dates available at the moment.