Joanne L.
Passionate About Innovating Healthcare Solutions | FDA reviewer: SaMD, cybersecurity, usability/human factors testing, 510(k)s and De Novos
- Role
- Lead Reviewer at FDA
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Joanne L.
Experienced technical manager: planning, budgeting, time management. Skilled in medical…
Experience
Lead Reviewer
Jan 2024 — Present
Subject matter expert reviewer for software, medical device data systems (MDDS), mobile medical applications. I also review cybersecurity (AAMI TIR57, ISO 14971), electromagnetic compatibility (IEC 60601-1, 60•••42), labeling, usability/human factors testing, cadaveric studies, performance testing (e.g, ASTM 2554). Additional review experience for biocompatibility (ISO 10993) and reprocessing/cleaning for reusable instruments. Lead reviewer of 30+ medical device regulatory submissions,(e.g, premarket notification of new medical devices (510(k) submissions) and pre-submissions (Q-subs, submission issue requests, De Novo and STeP applications, etc.)) as well as post-market compliance activities (e.g, medical device reporting, allegations and recalls).Serve as primary point of contact between Agency and external stakeholders; communicated regulatory policies and identified missing information needed for complete assessment of safety/effectiveness profile of devices. Led project meetings to align expectations and earn concurrence from senior leadership.Assess risks, safety and effectiveness of novel device along with testing plans and reports for complex devices such as stereotaxic orthopedics devices, patient-matched implants and guides, augmented reality, artificial intelligence and algorithm-based segmentation/software.
Education
UC Irvine
Master of Science - MS
UC Irvine
Doctor of Philosophy - PhD
University of California, San Diego
Bachelor of Science (B.S.)
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