Advantu is a veteran-owned small business. We’ve brought together a team with combined experience of over 60 years as leading domain experts, successfully delivering solutions for medical device software, biotech, and biopharma. Medical devices are in our DNA. Our team is comprised of hardware and software engineers with decades of medical device project experience – with a history of successfully delivering projects at companies such as CareFusion, Medtronic, Becton Dickinson, Hospira, ICU Medical, GenMark and Baxter.
We bring our expertise to your business to solve challenges that improve quality, help prepare for regulatory submission, reduce risk of recall, help speed products to market, or supply additional resources when you are short-handed.
At our core:
- IUV Intended Use Validation
- QMS Medical Device Quality Management System
- DHF Design History File Gap Analysis
- QA and Testing Support
- SDLC Software Development Lifecycle
- MedTech Software Engineering
- FDA Compliance Knowledge
- IVDR In Vitro Diagnostic Regulation Compliance