Services.
With Nancy's experience in electronic & software engineering, and Brian's background in medical devices, clinical diagnostics and software QA - and both familiar with how Agile technical and management practices really can serve a vital need across all these fields - we are a team that is well able to give you solid advice.
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TrainingOur most popular course is our full-day "Intro to Agile Adoption for Regulated Medical Software" which we present on-site for clients, or at selected conferences such as SDMD (Software Design for Medical Devices).
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CoachingWe offer coaching for all roles from hardware development to QA to Regulatory Affairs to enable you to implement all you learn in our training courses. A client in the UK received our help for a new project, and soon found they could deliver a related project that they'd given up on. This was due to the "Story crafting" skills and de-scoping strategy they learned - all remotely.
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Customized assistanceWe also offer
* Document review for FDA and other regulatory bodies * Review of your 510K submission * Diagnostic help and recommendations for stalled Agile adoption initiatives |
We Craft Elegent Solutions with Powerful TeamworkOur collaborators are experts in their areas - from Agile technical practices to domain knowledge from other kinds of businesses. Although we have broad experience, no one knows everything! We are glad to bring in the right people to address our clients' needs. Our goal is to help you become self-sufficient in Agile skills and concepts as quickly as practical.
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Our Customers Come FirstSafety-critical product work, especially medical devices, is missing out on tremendous benefits that Agile methods can give. Our mission is to change that!
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We Promise You the BestIn 2009 Brian Shoemaker had been working as an independent validation consultant to FDA-regulated companies, and Nancy Van Schooenderwoert had been coaching Agile teams for ten years in the US, UK, and Germany. We met at a Boston area professional group's event and learned that we had ideas and skills useful to each other's clients. We began to give presentations together, and then training courses. We've seen Agile grow and along with it our clients have needed more of our mix of "Agile mindset" plus regulatory awareness and practical teamwork for technical teams and for managers leading change.
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