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Tuesday, July 29 • 14:00 - 15:15
Agile for Safety-critical & Regulatory-Bound Products (Agile where you can kill someone) (Nancy Van Schooenderwoert, Brian Shoemaker) FILLING

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Many organizations that provide regulated, high-assurance, safety-critical software and hardware development struggle with Agile. High-assurance products are ones that may risk human life and health. Product development challenges include audits, regulatory documentation, risk management, safety, security, and traceability.



Based on our experience using Agile with medical device software and hardware, you learn how to initiate and maintain Agile practices for these types of systems.



We share how tools like story and impact mapping are integrated into product development. We explain how to use safety stories, integrate traceability using your story map, and specify tests to address safety and hazard mitigation requirements. We share how to proactively conduct incremental hazard analysis and mitigation and formal design review to satisfy regulatory requirements. And we’ll explain how stakeholders—including marketing, engineering, and service—can share a coherent vision early in development to support the special demands of the high assurance products.



This presentation is relevant to all types of high-assurance software and hardware development projects. Join us as we show how you can use a lean process to develop these types of products, which are so important for health and safety in modern life. Using actual medical device examples, we show how to create thin vertical slices of organizational activity to deliver fully compliant, high quality, high assurance, customer value on time.

Speakers
avatar for Nancy Van Schooenderwoert

Nancy Van Schooenderwoert

President, Lean-Agile Partners, Inc.
Two key interests: Agile Engineering, Agile Contracts. | | I'm interested in bringing Agile and Lean ideas to engineering disciplines beyond software - especially where it matters most: safety-critical products that simply HAVE TO WORK. Been doing this for many years; now seeing a big increase in demand for it. If you're an EE, ME or other engineer wanting to be Agile, let's talk! | | Boundaries between companies get in the way of trust... Read More →
avatar for Brian Shoemaker

Brian Shoemaker

Principal Consultant, ShoeBar Associates
Brian Shoemaker consults for healthcare products companies in 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... Read More →



Tuesday July 29, 2014 14:00 - 15:15
Osceola 4