“[W]e have received a very nice letter from the FDA indicating that they have ‘determined the device substantially equivalent to the legally marketed device…’. Needless to say we are very happy with that. Thanks so much for you help and insight. You’ve made a great difference for us.”

Yves Theriault
Project Manager / Gestionnaire de projet
OpSens Medical

“It was a great learning being part of IEC 62304 and emerging standards SoftwareCPR training at Sunnyvale. The training was well structured, embedding standards like ISO 14971, IEC 82304 and TR 80002-1 into IEC 62304 framework. The Industry and regulatory experts Brian Pate and John Murray delivered the sessions impeccably sharing their rich experience and numerous real-world examples. Training was interactive and facilitated to learn with many group activities. I would highly recommend this training to members working on software medical device and digital health products.”

Kamala K Nanjundeshaiah,
Regulatory and Quality Specialist,
Varian Medical Systems

“My team and I participated in the 2020 ‘62304 and Emerging Standards for Medical Device and HealthIT Software’ course.  The course outline is set up extremely well, it addresses all aspects of medical device development, and the outline and pace are as such that different functions (engineering, regulatory affairs, product development, marketing,…), experts as well as less experienced persons will learn from each other.  I especially enjoyed how the course leaders, Brian Pate and John Murray, interact with the participants.  These domain experts know how to create an open learning environment, where everyone feels comfortable to ask questions, share knowledge and experience, and are open for each others suggestions. Also my compliments on the course materials, very comprehensive and received well in advance of the course.”

Esther Abels
VP Regulatory Affairs, Clinical Affairs and Strategic Business Development

“I recently attended the 2020 SoftwareCPR’s course ‘62304 and Emerging Standards affecting Medical Device, Medical Mobile Apps, and HealthIT Software.’  The two instructors, Brian and John, brought a wealth of knowledge to the training and kept us engaged with many relevant examples and group challenges.  I particularly appreciate the practical answers to any real-life challenges the participants brought to the training.  I would recommend this training for its practical approach to difficult topics such as Agile methodology in regulated environment.”

Irina Smith
Supervisor, Software QA
Carl Zeiss Meditec, Inc

“I’ve had the chance to work with SoftwareCPR several times from 2003. Everything started with one of their extraordinary courses of software validation and I was already amazed about the quality and the professionalism. Since then they have always be ready to help me to create a SW validation QMS in two companies (procedures and templates), several coaching with 510K and PMA submissions and even a third party neutral assessment of the quality of their code. Each time they have proved that they know what they do and they know how to help you. Always a pleasure and a success! Thank you Alan, Raffaele, and Brian!”

Asun Rubio
Program Manager
Coat-X, Switzerland

“I would like to thank and congratulate my friend Brian Pate and the SoftwareCPR team for their latest training course “Being Agile…& Compliant”, held this week in Tampa FL. It was a privilege to be a participant. The course materials were on point and easy to follow, and supplemented with real life scenarios and best practices. An added bonus was the presence of FDA veteran John Murray and SoftwareCPR founder Alan Kusinitz, who were able to add additional nuggets of wisdom. I can thoroughly recommend this to anyone developing medical devices with software either already using or considering deploying Agile development processes.”

Ian West, Ph.D
R&D Executive, Product Commercialization

“I want to say that was a fantastic training with lots of great information and practical points! Thanks!”

Jared McDonley, Quality Systems Manager, OneBlood
2019 “Being Agile and Compliant” Course Attendee

“Many thanks for a brilliant training session, very lively, engaging talk with scenarios and examples to understand the concepts.  The collective feedback from our team after the training was that it was very informative, valuable, and presented in a digestible format.”

Ram Kannan, Quality Manager, Planet Innovation
Melbourne, Australia
2018 62304 Training Course Attendee

“Thanks Brian Pate, this was truly a fantastic course, full of great information, along with pragmatic real world examples…highly recommend all #software engs who work in #MedicalDevices booking Brian for this course.”

Adrian Higgins, Software Development Manager, Planet Innovation
Melbourne, Australia
2018 62304 Training Course Attendee

“Thanks again for the training the last 3 days. Both that and the 62304 assessment were valuable activities and I believe we learned a lot that can be incorporated in to our day to day work. Overall it was a fantastic experience working with your organization.”

Travis Dahlen, Director of Software Development
Minneapolis, Minnesota
2018 62304 Training Course and SDLC Assessment

“I worked with Brian Pate, Paul Felten, and the rest of the SoftwareCPR team a number of times when I was leading our software V&V team at HeartFlow. There were many great parts about working with SoftwareCPR!

The team comes from a range of backgrounds and if one person doesn’t know an answer to your question, there will always be someone else at SoftwareCPR who does.  They’ve worked with so many different clients that they seem to always have an example that is relevant to a problem or challenge you’re facing.  They genuinely want to help you and your company improve. Consulting isn’t just a job for them; they care about seeing their clients succeed.

Brian came in to work with HeartFlow ahead of our first 510(k) filing and helped shape up our design controls as more specifically (for me) our V&V processes.  I led the V&V team from 2013 to 2018 and based on his consulting, advice and feedback over those years, I never had a non-conformance in an audit that was attributed directly to the V&V team.  I have Brian and SoftwareCPR to thank for that; they started me out on the right foot from the very beginning!”

Rachel Entwistle, Director of Program Management
Redwood City, CA