With more than 35 years of experience in designing and manufacturing fiber optic products and solutions for the medical industry, OFS today continues to innovate in this area, working closely with its customers to help bring life-saving, life-enhancing medical technology to market.
From the glass preform to the optical fiber and cable design to the finished probe assembled in a low-bioburden room, OFS’ engineering and manufacturing expertise help make vision and custom design a reality.
OFS is ISO13485 certified, follows good FDA Good Manufacturing Practices, and tests fibers to USP Class VI standards and ISO10993 for biocompatibility.
There are more than a few companies who can manufacture silica optical fibers, but here are a few key points that set OFS as industry leader.
- Understands the medical industry and can provide quality support along with ISO 13485 certification
- Maintains Device History Records and retains data for an established period
- Environmentally Controlled Manufacturing Rooms for low bioburden assembly manufacturing are available
- Uses a vertically-integrated manufacturing system: preform, fiber, cable and assembly
- Maintains biocompatibility test records and certificates
- Has experience supporting new product development and has the capability and experience to scale up to volume production.