Rapid Prototype Development

 

At Sirius, we have a full machine shop and lab for rapid prototyping and iteration, extensive equipment for testing, and certified clean areas for manufacturing . Most of all, we have the ability and knowledge to make it happen.

 
 

prototype fabrication

CAD modeling (SolidWorks), 3D printing, Silicone and plastic molding, Proprietary PTFE (Teflon) stent coating, Vacuum ovens, Furnaces, Compression molding, Nitinol (NiTi) stent forming/shape setting, Catheter tipping, Thermal bonding, and more…

 

Laser Finishing Needle Small Hypotubes

Custom Nitinol Stent and Prosthetic Implant Design

 

Class 7 clean room AND LAMINAR FLOW HOOD

Cleanroom Suite

Certified and Monitored ISO Class 7 Clean Room and ISO Class 5 Laminar Flow Hood (LFH) for Pilot Manufacturing.

 

verification testing

Verification & Validation Equipment

Torque, tensile, and compression testing, Ex vivo bench top testing, Fatigue testing, and Application specific fixture design, manufacturing, testing, and reporting.

 

Trustworthy Experience

 
 

Industry Expertise

Surgical expertise, FDA compliant Quality System development and deployment, FDA pre-market regulatory submissions