DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: An Incremental Approach to Risk and Quality Management" conference has been added to ResearchAndMarkets.com's offering.
Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management.
Techniques for risk management are well established, but require specific interpretation when applied to software. In this session, we will show a way of knitting risk management into the development process, so that it is integral to product development, not a ten ton caboose dragging the train back down the mountain.
Why Should You Attend?
Perhaps your engineering team is beginning its transition to an Agile approach - or perhaps you have a seasoned Agile team and you're just beginning work on FDA-regulated products. You know that risk management is required, but it's not at all clear how you should address it as you go through your backlog grooming, iterations, and end-user demonstrations. The process in ISO 14971 seems "linear" and unsuited to a highly iterative, dynamic lifecycle. How can you fit it into your approach?
Day 1 Schedule
- Lecture 1: Software brings great capability to medical devices, but also creates hazards
- Lecture 2: Consider how the key standards lay out the roadmap for managing risk
- Lecture 3: Understand the key concepts - hazard, risk, and harm
Lecture 4: Walk through ISO 14971 in detail - and consider IEC 80002-1
for specific software concerns
Day 2 Schedule
- Lecture 1: Fault tree analysis and FMEA complement each other for risk analysis
- Lecture 2: Risk analysis for software is different from hardware - and needs a place in the lifecycle
- Lecture 3: Story mapping helps bring risk management directly into development
- Lecture 4: An incremental approach manages both risk and quality
For more information about this conference visit https://www.researchandmarkets.com/research/jq2wv7/2_day_seminar?w=4