Past event: Medical Device Software: An Incremental Approach to Risk and Quality Management Seminar

Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien.

Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world.

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 you should 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?

Areas Covered in the Session:

• Software has introduced (or been blamed for) some serious safety hazards
• All medical device standards intersect on the topic of risk management
• Risk analysis starts with the intended use statement
• Risk information is available from multipl sources - use them!
• Note that safety is an emergent property
• Changes are often the biggest sources of risk
• Don't ignore the human factors side; understanding your users is crucial to safety
• Applying engineering risk methods to software requires us to translate some concepts
• Though standards draw a roadmap for risk management, WE must figure out the route
• Risks often arise when we add new features - so incremental risk management is the most effective
• Forget the notion that "software can't hurt anyone"
• Never conduct risk analysis by using a checklist from 14971
• Exploding technology brings numerous chances for risk to multiply

Who will benefit:

• Project managers
• Regulatory specialists
• Quality assurance specialists
• Documentation specialists
• Test managers
• Software team leaders and lead developers