LASER COMPONENTS Receives Certification according to EN ISO 13485 - Optical Fibers for Medical Applications
LASER COMPONENTS develops and manufactures optical, optoelectronic, and fiber-optic components for medical applications, including disposable and reusable fibers.
We invest in reproducibility; our quality management system is certified according to EN ISO 13485 and
ISO 9001. This means that:
- All medical product materials and packaging meet biocompatibility requirements according to DIN EN ISO 10993-1 depending on their intended purpose.
- All relevant production steps are validated and documented.
- The traceability of even the smallest component is ensured.
- Our cleanrooms are certified according to GMP and DIN EN ISO 14644.
- All fiber optics are produced under reproducible cleanroom conditions according to ISO classes 7 and 8 for use in medical technology.
- We also deliver sterile products to our customers upon request. Here, it is crucial to meet the packaging requirements according to DIN EN ISO 11607 and DIN EN 868 and ensure a validated sterilization process according to EN ISO 11135-1.
- We generate technical documentation on our in-house processes.
- Before we start designing a product, we carry out a risk analysis according to DIN EN ISO 14971.
