Description

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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

Day 1 Schedule

Software brings great capability to medical devices, but also creates hazards

Consider how the key standards lay out the roadmap for managing risk

Understand the key concepts - hazard, risk, and harm

Walk through ISO 14971 in detail - and consider IEC 80002-1 for specific software concerns

Day 2 Schedule

Fault tree analysis and FMEA complement each other for risk analysis

Risk analysis for software is different from hardware - and needs a place in the lifecycle

Story mapping helps bring risk management directly into development

An incremental approach manages both risk and quality

Brian Shoemaker

Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Please contact the event manager Marilyn below for the following: 
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase. 
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS 
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