Get your FDA clearance to market by performing your benchtop testing with us.

Bioana has an ISO 17025 certified testing laboratory that can help you with your mechanical, material and packaging testing to ensure safety and efficacy in your product for FDA regulatory submissions.

We can provide a substantial equivalency testing file for a 510k.  

Standards:

Is your product a new development and need testing to your specific requirements?

Our R&D department is set up to flexibly react to your testing needs and help you design a customized testing protocol for your device.
Contact us →
Schedule a call today

Got any questions?

Schedule a Call