Welcome!
If you have a safety-critical application and / or an absolutely fixed deadline for your project, and you want to know if Agile methods can help - you've come to the right place.
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This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition.
Our book "Agile Methods for Safety-Critical Systems" is now available through Amazon. Click on the link or the book image to go directly to the Amazon page. - Nancy Van Schooenderwoert and Brian Shoemaker For a preview of the book, click here. |
What the Experts are Saying...
I heartily recommend the timely and provocative new book, Agile Methods for Safety Critical Systems, by Nancy Schooenderwoert and Brian Shoemaker for next-generation software developers and innovators. Using examples around safety critical medical devices, the authors reveal counter-intuitive means of moving beyond older software methods to be able to consistently produce previously unachievable levels of quality, while simultaneously increasing the speed of production! If that seems impossible, you need to pick up this book!
Jack Lewin MD, Founder and Principal, Lewin and Associates LLC
Brian and Nancy have written a primer on Agile programming that emphasizes quality. This is just the sort of message that should be appreciated by software professionals using Agile in safety-critical domains. Well done!
Rick Chapman, former FDA Branch Chief
This book describes very proven and pragmatic approaches to agile, and does so in plain language.
Agile methods deliver value. This primer addresses the many challenges that medical device organizations might face in adopting Agile, and provides good recommendations for things to consider and solutions to pursue. I hope this primer helps encourage anyone in a safety-critical environment to realize the benefits that Agile methods can provide.
Kelly Weyrauch, Principal at Agile Quality Systems, Lead author of AAMI TIR45
Nancy and Brian answer an emphatic “YES!" to one of the most common concerns about use of Agile methods, whether they can be used in safety-critical questions. In doing so, they provide an excellent introduction to Agile ideas, combined with advice specifically useful for Agile projects with higher need for reliability and quality. In this short and readable book, they give a look at all the key ideas you need to know, plus a host of references for gaining deeper knowledge. Highly recommended!
Ron Jeffries, Agile Manifesto Author, ronjeffries.com
Who says you cannot use agile for regulated medical device development? Nancy and Brian not only show you that you can, they make a compelling case for Agile and its approach of building in quality from day one. This book will help you see how to meet FDA process and documentation demands with Agile's iterative and incremental approach.
James Grenning, author Test-Driven Development for Embedded C and Founder of Wingman Software.
Jack Lewin MD, Founder and Principal, Lewin and Associates LLC
Brian and Nancy have written a primer on Agile programming that emphasizes quality. This is just the sort of message that should be appreciated by software professionals using Agile in safety-critical domains. Well done!
Rick Chapman, former FDA Branch Chief
This book describes very proven and pragmatic approaches to agile, and does so in plain language.
- This book is the facilitator as you start your agile journey
- Pragmatic and plain spoken
- The best introduction to agile I’ve read, and it is written for medical devices.
- Provides a rare, holistic view of agile – for developers, for managers, for Regulatory, for Compliance
Agile methods deliver value. This primer addresses the many challenges that medical device organizations might face in adopting Agile, and provides good recommendations for things to consider and solutions to pursue. I hope this primer helps encourage anyone in a safety-critical environment to realize the benefits that Agile methods can provide.
Kelly Weyrauch, Principal at Agile Quality Systems, Lead author of AAMI TIR45
Nancy and Brian answer an emphatic “YES!" to one of the most common concerns about use of Agile methods, whether they can be used in safety-critical questions. In doing so, they provide an excellent introduction to Agile ideas, combined with advice specifically useful for Agile projects with higher need for reliability and quality. In this short and readable book, they give a look at all the key ideas you need to know, plus a host of references for gaining deeper knowledge. Highly recommended!
Ron Jeffries, Agile Manifesto Author, ronjeffries.com
Who says you cannot use agile for regulated medical device development? Nancy and Brian not only show you that you can, they make a compelling case for Agile and its approach of building in quality from day one. This book will help you see how to meet FDA process and documentation demands with Agile's iterative and incremental approach.
James Grenning, author Test-Driven Development for Embedded C and Founder of Wingman Software.
Services We Offer
Training
We offer training courses and workshops in Agile topics, and Regulatory topics - all with an understanding of how companies can get the full benefits of Agile while staying fully compliant! You don't have to "water down" Agile's power at all.
Ongoing Support
Even clients who've mastered the basics still have a desire to keep pace with new developments in Agile and in the regulatory world. We develop new training all the time. They say a picture is worth a thousand words. We think an experience is worth a thousand pictures! So we like to design our training around experiences. These give an "Aha! moment" and really stick!
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Coaching
Coaching bridges the gap between training and actually making the new ideas work inside your company. We coach from experience of having actually used Agile practices to deliver.
Customized Assistance
We offer specific help such as review of FDA documentation prior to submission, review of SOPs, review of Agile Story backlogs, etc. Our custom services were created to serve the needs of medical device companies that needed reviews done with an awareness of how Agile practices fit in.
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