“Andrew Dallas provided development and quality assurance services at various points during a three-year FDA 510(k) medical device submission process for our IVD instrument at Primera Biosystems. His deep experience in regulatory documentation gave us confidence in creating adequate supporting material that avoided review snafus from FDA and ISO reviewers — both of which passed successfully. He was flexible in carving out work between in-house and external consultant teams. The work was cost-effective and high quality. I highly recommend working with him at any stage of development.”
— Kyle Hart (Director, Primera Biosystems)
“Working with Andrew Dallas and his team delivered exactly the kind of partnership we needed. They combined deep software and systems expertise with practical regulatory knowledge, helping us meet aggressive milestones on a complex infusion pump system for warfighter medical care. The collaboration de-risked our development efforts significantly while keeping us on time and on budget.”
— VP of Engineering & Clinical Research (Medical Device Client)
“Andrew Dallas brought highly effective engineering leadership across multiple projects and companies. He went far beyond the initial scope, transforming our observability, QA processes, triaging, and agile methodology. His ability to understand complex product portfolios and implement practical, high-impact recommendations is rare and extremely valuable in the MedTech space.”
— EVP & CTO of Product and Operations (Multi-company collaborator)
“After founding Full Spectrum Software in 1996 and leading hundreds of medical device projects through regulatory clearance and commercialization, I created DallasMedTech to deliver the same high-impact results — but faster and with modern AI tools. Our clients consistently see accelerated timelines, smoother FDA/ISO compliance, and measurable productivity gains.”
— Andrew Dallas Founder, DallasMedTech & Full Spectrum Software