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.

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Nancy was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. She has led Agile change initiatives beyond software development in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods. Nancy has worked coaching Agile teams in the USA, UK, and Germany. Her coaching extended to their work with their teams in Japan, India, China and other countries. Nancy provides specialized consulting to medical device companies in partnership with Brian Shoemaker of Shoebar Associates. Together they cover all the latest regulatory developments in the US and EU, plus the Agile practices for documentation and incremental risk assessment that is essential for their industry. Nancy's experience spans embedded software and hardware development for applications in aerospace, factory automation, medical devices, defense systems, and financial services. Her coaching practice spans delivery teams to middle and upper managers. She is a regular presenter at Agile-related conferences since worldwide. She is a founder and past president of Greater Boston’s premier Agile user group, Agile New England.