Windi Hary joins SoftwareCPR

Tampa, FL, May 10, 2023.  Crisis Prevention and Recovery, LLC, dba SoftwareCPR® announced today that Windi has joined SoftwareCPR® as a Partner. In her role, Windi will lead the expert regulatory and quality team, bringing a unique client-side perspective for both US, Canada, UK/EU, and Japan markets.

Windi’s career path is one marked by a series of ascending leadership roles since she completed her master’s degree at Stanford and began her career as a Quality Systems Specialist at Stentor/Philips Healthcare in 20002.  By 2006, she was managing a team performing audits, post market surveillance activities, and regulatory submissions for US, Canada, and EU markets.  It was at that time that she joined Silicon Valley unicorn Heartflow, Inc., where she masterminded the regulatory strategy for the first ever AI-enabled cardiology diagnostic SaMD.  During her time at HeartFlow, she achieved C-level roles and managed global regulatory submissions.  Windi’s career has been marked by consistent and significant accomplishment.

“I love finding the common sense and value within quality and regulatory compliance.”

Windi received her M.A. from Stanford University and a Magna Cum Laude graduate of Vanderbilt University. She currently serves on the ASME V&V40 Subcommittee Verification and Validation of Computational Modeling of Medical Devices and the MITA Working Group for Artificial Intelligence (AI).

As a partner at SoftwareCPR®, Windi looks forward to continuing to share her expertise with industry through consulting, coaching, and training. For more information and to contact Windi, you can email her at or call our office at 781-721-2921.

Read Windi’s recent post on the FDA PCCP: FDA Predetermined Change Control Plan

About SoftwareCPR®: For over 20 years, SoftwareCPR® has provided expert advice and guidance for software, regulatory, risk management, validation, and 21 CFR Part 11to medical device, pharmaceutical, and blood establishment computer system manufacturers.

SoftwareCPR® also provides full FDA enforcement action crisis recovery, premarket submission, and quality system training and consulting services with a focus on client culture, business goals, and efficiency as well as device safety and effectiveness.

Media Contact:

Brian Pate
General Manager

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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