Tampere, Finland--Laser diode and laser systems manufacturer Modulight received ISO 13485:2003 certification from Det Norske Veritas (DNV). ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. The new registration comes as an addition to Modulight’s ISO 9001:2008 and ISO 14001:2004 certifications received in 2002 and 2004, respectively. The certification insures that the company has the fundamental quality management systems in place for manufacturing lasers for a variety of applications and now including the medical equipment market.
Modulight is a vertically integrated laser diode manufacturer with design and manufacturing capabilities from chips to complete laser systems in the wavelength range from 630-1650 nm. The company has offered OEM laser solutions to the medical market for several years in such applications as fluorescence, photodynamic therapy, surgery, and dentistry. The addition of the ISO 13485 certification further supports Modulight's strategy to offer OEM laser component and system solutions for original medical equipment manufacturers. Apart from the wide variety of component solutions, Modulight also offers SparkLight turnkey laser systems that are designed to meet the safety and design requirements of medical applications. The Sparklight laser platform can be adapted to power any of Modulight's high-power lasers, offering broad wavelength coverage. The same wavelength range is supported with a lower power (400 mW to 2W) and more compact LimeLight laser system based on fiber-coupled single-emitter lasers.
Modulight president and CEO Petteri Uusimaa said, "We are very satisfied that DNV audit confirms our own and 2nd party experience on the fact that our QMS is functional and effective, and provides benefits to our customers. We clearly see the need for medical equipment manufacturers to rely more and more on external design and manufacturing expertise in the fast developing laser field. We have already helped a number of companies in medical and life-science markets to save costs and improve the performance of their system by choosing our tailored laser solutions. Having the ISO 13485 certification in place allows us to offer also turnkey laser solutions to medical equipment manufacturers, including possible 3rd party type approval for a complete laser system for our customer."
Modulight products include various types of lasers from visible to infrared wavelengths with output power levels from milliwatts to hundreds of watts. Modulight also offers laser solutions from design and manufacturing of laser diodes to OEM-based optical sub-systems and turnkey laser systems. Modulight owns and operates a semiconductor fab in Tampere, Finland and has a fully owned subsidiary Modulight USA in San Jose, CA.
SOURCE: Modulight; www.modulight.com/press_news58.htm
