FDA 501(k) approval experience
HIPAA compliant solutions
Headway designs and develops software that powers connected MedTech solutions that are both industry-compliant and meet your customers' needs. We have partnerships with RA/QA experts to ensure your solution meets the necessary compliance requirements.
Our close partnerships with electrical device and hardware experts include SaMD design and development, MedTech go-to-market launches, GPO navigation and approved vendor status for hospitals, and software-enabled disposable device design.
Our designers and developers have the experience and ability to resolve complex challenges to deliver remarkable patient and provider experiences. Lean into our proven process and approach to creating impactful solutions to the market quickly and effectively.
Biosensor Launch Lead at One Drop