There is just one more step between design and manufacturing and that is the design transfer process, where our product development and manufacturing team join forces to ensure the design is ready for actual production and achieve a smooth transition into manufacturing. With our process we have avoided common setbacks or pitfalls that happen while transfering a design to manufacturing.
At Bioana we offer scalable manufacturing and assembly services for medical devices. Our facilities are capable of handling both low-volume and high-volume production depending on the project needs. We count with white assembly areas and cleanrooms (ISO 7, ISO 8, and ISO 9) that allow us to provide a wide range of assembly and packaging capabilities services depending on the product requirements. Our equipment includes: CNC machines for mold production, Injection Molding Capabilities and Packaging Equipment.
We follow strict quality controls to deliver high quality finished medical devices on schedule, always focusing on continued improvement to deliver cost reductions and efficiencies.
Our facility is FDA registered and compliant with FDA’s CFR 820 Quality System Regulation. Bioana is in the process of obtaining its ISO 13485 Certification (coming soon 2023).
“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.