Tampere, Finland, Oct 6th 2011 – Modulight, Inc. based in Tampere, Finland and San Jose, CA, announced the company has 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 ISO 9001:2008 and ISO 14001:2004 certifications received by Modulight in 2002 and 2004, respectively. It assures that the company has the fundamental quality management systems in place for manufacturing lasers for a variety of application, now including also medical equipment market.
Modulight is a vertically integrated laser diode manufacturer with design and manufacturing capabilities from chips to complete laser systems over the wavelength range from 630nm to 1650nm. The company has offered OEM laser solutions to medical market already for several years, including applications like 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 a broad wavelength coverage: 635 nm (4 W), 650/690 nm (5 W), 808 nm (35 W), 980 nm (35W) and 1470/1550 nm (15 W). Same wavelength range is supported with a lower power (400mW to 2W) and more compact LimeLight laser systems based on fiber coupled single-emitter lasers.
Modulight’s President & CEO, Dr. 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. Adapting our processes and products to support medical laser equipment manufacturing is an important milestone for the company and assures our medical OEM customers that our manufacturing processes support directly their product control and approval processes. 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. By choosing a laser expert like Modulight as a partner, they will ensure to have the latest and most cost efficient laser technology going into their products which often can be the final differentiator from their competition. 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. We are already doing this for some companies right now and they are seeing the benefits in the form of saving time and money by us choosing the right technical solutions and meeting their end-user requirements from the very beginning. It has also been an exciting experience for our engineering team to learn more about laser applications in healthcare field and see how we can contribute to a better life for all of us.”
About Modulight, Inc.
Modulight, Inc. provides value-added solutions to optical applications for industrial, communication, medical, space, and defense industries. Modulight products include various types of lasers from visible to infrared wavelengths with output power levels from milliwats to over hundreds of watts. Modulight provides also 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 fully owned subsidiary Modulight USA located in San Jose, California.
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