Custom Assemblies for Medical Technologies

Customer-specific Assemblies for Medical Technology

High demands are placed on product and quality management especially in medical technology. As a certified manufacturer, development partner, and OEM manufacturer, LASER COMPONENTS meets all these criteria. The manufacturing and packaging of our medical assemblies takes place in a class 7 or 8 cleanroom. All fiber assemblies are produced in Germany.

We manufacture sterilely-packaged invasive products (bare fibers, custom fibers, fibers with processed end faces) for numerous medical areas such as kidney stone fragmentation, pneumology, and tissue ablation. The product range also includes acupuncture fibers for laser acupuncture.

Manufacturing and Quality Management

LASER COMPONENTS unites all of its facilities and its capacity for the development and production of custom solutions in medical technology under one umbrella. With ISO 13485 certified production, an integrated cleanroom, and a development team specialized in fiber optics, we develop and manufacture numerous new solutions for our customers – from special fiber-optic assemblies to optical assemblies.

Since miniaturization is also increasingly being sought in optics, fiber optics is a promising field for many users. Today, optical coherence tomography (OCT) solutions, medical probes for examinations and operations, special laser acupuncture solutions, and metal-free on/off switches are developed and manufactured based on fibers. Our experienced teams from production and development are sure to find the right solution for you!

• All materials and packaging of medical devices meet the biocompatibility requirements of DIN EN ISO 10993-1 depending on their intended purpose.
• All relevant production steps are validated and documented.
• Traceability is guaranteed down to the smallest component.
• Our cleanrooms are qualified according to GMP and DIN EN ISO 14644.
• All fiber optics for medical technology are manufactured under reproducible cleanroom conditions in ISO classes 7 and 8.
• We also deliver sterile products upon customer request. The packaging requirements are fulfilled according to DIN EN ISO 11607 and DIN EN 868, and the validated sterilization process is guaranteed according to EN ISO 11135-1.
• We prepare the technical documentation for our processes in house.
• Before we start the product design, we carry out a risk analysis according to DIN EN ISO 14971.