Bioana is officially ISO 13485 certified!
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Bioana's medical product design and development process has been improved after each product iteration over the past 10 years. Thanks to this continuous improvement we have a proven track record of success in medical devices development, and we are able to create a “market ready medical product” rapidly and effectively.
Medical Device Design and Engineering is our specialty. For each product development project we integrate a creative, dynamic, technically skilled, and multidisciplinary team led by a Project Manager in charge of keeping the project on time and on budget, while assuring that Design Controls are implemented. We embed risk management into our Design Process right from the start, making sure that all Design Requirements generated are risk based.
At Bioana, we develop not only safe, effective, and cool looking devices, but we implement engineering best practices of Design for Manufacturing (DFM) and Design for Assembly (DFA) for a seamless transition to Manufacturing in order to make the device scalable and commercially viable.
At this phase, the transformation of a prototype to finished product happens. A finished product is not only the device in itself, but also includes the packaging design, labeling design, production process design and quality design. During the development, we make sure all of these aspects are taken into account in order to get to our ultimate goal of this phase: Design Freeze.
3D CAD Modeling
Mechanical Design
3D Scanning
3D Modeling (SolidWorks and SpaceClaim)
3D Model Rendering
Design Optimization
Design for Manufacturing and Assembly
Simulation and Finite Element Analysis
Engineering Analysis and Optimization
Material Characterization
Mesh definition and refinement
Structural Analysis
Fluid Dynamics Analysis
Thermal Analysis
Electrical and Electromagnetic Analysis
Prototyping and Assembly
3D printing FDM, SLS, SLA
3D Printing with Biocompatible resin
Silicone / Thermoplastics Casting
Plastic Injection Molding
CNC Machining
Laser Cutting/Engraving/Soldering
Ultrasonic Welding
“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, 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
CRO , Bolb Inc.