John McManus

Background

About John McManus

I am a regulatory professional, biochemist, and policy expert with over five years of experience in medical device evaluation, in vitro diagnostics (IVDs), and software as a medical device (SaMD). As such, I have detailed knowledge of all phases of the medical device total product lifecycle including evaluating analytical and clinical validation strategies, reviewing pre-market requests for class II and class medical devices, and ensuring compliance with FDA regulatory frameworks for medical devices, such as those associated with 21 CFR 820. Furthermore, I am an expert in writing, implementing, and interpreting FDA regulations and policy. Finally, I am spearheading alternate validation approaches for medical devices, for example, the use of real-world data to support device clearance. I am an expert in several life science fields with a proven track record for basic research in microbiology, enzymology, and polymer science. I have also demonstrated an ability to translate basic research findings into meaningful deliverables, such as the prototype environmental sensor I developed during my time at Caltech.