This programme is funded by Connected Health Skillnet
Connected Health Skillnet is co-funded by Skillnet Ireland and network companies. Skillnet Ireland is funded from the National Training Fund through the Department of Further and Higher Education, Research, Innovation and Science
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
Pertinent Regulations & Standards
Process Overview
Intended Use & Device Risk
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
08 - 10 June 2021 (9:30 - 17:00)
Online - virtual classroom