At ZP we are the leading independent contract developer and manufacturer of electrochemical biosensing technologies.
As part of our full turn-key solutiosn we also provide consulting around regulatory approval (QARA), including the strategy of getting your product to FDA approval.
One tactic to achieving a 510 K approval for your hardware is to make the first release of your product as a cholesterol test, though cholesterol may not be commercially interesting it does allow you to get your technology onto the market with a relatively low regulatory barriers.
Please contact ZP to discuss our QARA services, our sensor development/manufacturing services, and our hardware development/manufacturing services.
