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 firstname.lastname@example.org 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.