About us
Meet the founders
James Bennett,
Quality Assurance
James is a passionate Quality leader with an immense drive for continuous improvement and 12+ years of experience in the realm of Post Market Surveillance and Quality Management Systems.
His specialty areas of focus include Complaint Handling, NC/CAPA, Document Control, Risk Management, Internal/External Audits, Supplier Management, External Standard Review, Quality Control, and Patient Device Tracking. ​​
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Originally from Australia, James currently lives in San Diego, California with his wife, son, and corgi. When he's not working, you can find him on his bike, gardening, or enjoying time with his family.
Jamie Wilson,
Regulatory Affairs
Jamie is a Regulatory Affairs Certification (RAC-US) holder with 10+ years in the regulatory affairs profession. Jamie has extensive experience navigating the complex landscape of medical device approvals and is passionate in his development of a creative global regulatory strategy.
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His specialty areas of focus include IDE, PMA, Special 510(k), FDA correspondence & meeting preparation, and EU MDR (2017/745).
Jamie resides in Texas and loves pugs, technology, cooking, and gardening. ​