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.  Our services include testing for:

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.
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Testimonials

“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”

Mark Lee

CEO at Ocumetics

"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."

Frank Harder

Chief Revenue Officer at Altus

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