Our Goal
Safety-critical product work, especially medical devices, is missing out on tremendous benefits that Agile methods can give. Our mission is to change that!
Consulting services we offer
Training
Our most popular course is our full-day "Agile Intro for Regulated Medical Software" which we present on-site for clients, or at selected conferences such as SDMD (Software Design for Medical Devices). For more about our courses see the Publications menu.
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Coaching
We 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 from us - all remotely.
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Customized Assistance
We also offer
* Document review for FDA and other regulatory bodies * Review of your 510K submission * Diagnostic help and recommendations for stalled Agile adoption initiatives |
Established since 2009
Each of us has been established in our own consulting work for many years. This web page describes services we offer together, and provides a landing place for people interested in our book and other publications.
In 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.
In 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.
We craft elegant solutions with powerful teamwork
Our 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. We help you become self-sufficient in Agile skills and concepts as quickly as practical - all while remaining fully compliant with FDA and EU regulatory needs.