We are all about fast tracking development of safe, effective, and high-quality medical devices so you can see your product saving people’s lives or improving their health.
Concept development – Industrial Design
MVP Prototypes for market testing
Design for Manufacturing and Assembly
Small Batch Prototype Production for Testing
FDA 510k Clearance and registrations
Expand your in-house R&D and Engineering team
Product portfolio upgrades/improvements
Substantial Equivalence Benchtop Testing for 510k
Product Quality Testing
We’ve been working since 2013 in refining our development process, to make it faster, better at mitigating risk, and with a team of experts that know how to avoid common pitfalls.Contact us
Fill out our contact form or schedule a call with us. We can also send a mutual Non-Disclosure Agreement.Contact us →
Together we'll discuss your project and the next steps to take.
We'll prepare a proposal based on your needs.
The moment we've been waiting for. It's time to get your product to market.
We help our clients transform their ideas and market opportunities into safe, cost-effective and innovative medical products through a fast-systematic design process.
We are good in identifying the real problem to solve.
User Centered Approach
We design the correct product for market success.
Design for Manufacturability
We design products that can be built for a seamless transition to production.
If the product is both necessary and useful, then we don’t hesitate to make it beautiful.
We have specialized experts in the field.
FDA Quality System and Design Controls
Quality is embedded into our system, as a disciplined approach to innovation, that empowers the best results in a faster way.
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
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."
Chief Revenue Officer at Altus
We will provide you with a fast-track development of a safe, effective and ready to sell product delivered on-time and on-budget for you to become the first to reach the market, a real innovator. We want to help you achieve the satisfaction of seeing your product saving patients lives or improving their health and quality of life.