Bioana offers a range of bench-testing services for medical devices, from early proof of concept all the way through final V&V Testing for FDA Regulatory Submissions using production equivalent devices.
Alongside our sister company Metalinspec Labs, we are able to provide you with an ISO 17025 certified lab to perform your product testing using state-of-the-art equipment technology.
We test product performance, reliability, usability, safety and quality requirements according to internal protocols or product specific FDA Guidances, ASTM, ANSI, and ISO Standards, always using statistical processes suitable for regulatory submissions.
Bioana can also provide cruelty-free and responsible pre-clinical testing with different animal models whenever this testing is required by regulatory agencies.
• Verification Plan Documentation
• Bench Testing Protocols Design
• Custom Test Design
• Mechanical testing (Static and Dynamic) per ASTM and ISO tests
• Flow and Leak Testing
• Accelerated Aging Testing
• Product Quality Testing
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
"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."
CRO , Bolb Inc.