Thursday, March 3, 2016
Jenoptik optics company in the USA announces ISO-13485:2003 medical device registration
Jenoptik Optical Systems, LLC. (JOSI) is pleased to announce the registration of its quality management system to ISO-13485:2003 for medical device manufacturers or service providers. The certification covers both design and manufacture of medical devices.
The company successfully obtained the registration through Intertek on its first audit attempt, complementing existing registrations to ISO 9001:2008. JOSI completed the audit in late January, 2016 and received the official certificate of registration in March, 2016.
“JOSI has a history of providing reliable, cost effective products to a highly regulated customer base. In addition, with manufacturing locations worldwide, Jenoptik allows for immediate access to high quality, low cost components. JOSI also offers vertical integration of optical design, manufacturing and system testing. Achieving this milestone is a tribute to our team and its commitment to growth in diagnostic instruments for life sciences,” remarks, Jay Kumler, President of Jenoptik Optical Systems.
“This registration paves the way for expansion into medical markets where exceeding customer and regulatory expectations is a prerequisite,” said, John Racette, JOSI Quality Director.
As an integrated photonics group, Jenoptik operates within five divisions: Optical Systems, Healthcare & Industry, Automotive, Traffic Solutions and Defense & Civil Systems.
With its Optical Systems division Jenoptik is one of the few development and production partners worldwide for optical and micro-optical systems and precision components designed to meet the highest quality standards. The division offers solutions for optical glass, fused silica and crystals, infrared materials as well as plastic that can be coated in wavelengths from far infrared to DUV. Jenoptik also possesses outstanding expertise in the development and manufacture of micro-optics for beam shaping used in the semiconductor industry and laser material processing. The product portfolio of the division also includes solutions for optical information and communication technologies, as well as defense and security.