J D Giese is a partner and co-founder with 14 years of experience bringing software-heavy diagnostic medical devices to market, combining hands-on software development, FDA regulatory strategy, AI, cybersecurity, and medical imaging. He has led end-to-end development and fixed-price regulatory and validation programs that helped commercialize over 35 devices, and he specializes in rapid, auditable FDA cybersecurity documentation and 510(k) software validation. A former biomedical engineering grad student, he turned academic optics and microscopy research into a career focused on practical, compliant SaMD delivery for physician founders and VC-backed teams. He built and now leads the distributed team at Innolitics, writing and speaking frequently on medtech regulation while still enjoying hands-on coding and creative pursuits outside work.
13 years of coding experience
13 years of employment as a software developer
Bachelor Biomedical Engineering, Bachelor Biomedical Engineering at The University of Texas at Austin
Master's Degree Biomedical Engineering, Master's Degree Biomedical Engineering at Boston University
Contributions:303 reviews, 215 commits, 50 PRs in 1 year
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