Born from flexible illuminated fabric developed on a repurposed loom in 1985, Lumitex designs, develops and manufactures thin, integrated lighting systems for medical devices and other demanding applications. The Brecksville company works with medical OEMs from early concepts through prototyping, validation and production, with particular depth in surgical retractor lighting and phototherapy. Lumitex operates to U.S. FDA Good Manufacturing Practices and is certified to ISO 13485 and ISO 9001.
ISO 13485:2016 Quality Management System
certification
I.S. EN ISO 13485:2016 Quality Management System
certification
ISO 9001:2015 Quality Management System
certification
U.S. FDA Good Manufacturing Practices and Standards
compliance_program
MDD 93/42/EEC Annex II
certification
UL
certification
CSA
certification
CE Mark
certification
FDA Class I Medical Device
certification
MDR Class IIa Medical Device
certification
Global Lighting Technologies, IncFounded in 2000, Global Lighting Technologies develops custom LED light guides and takes them from optical design and in-house prototyping to high-volume production. The company pairs U.S.-based engineering and project management with nearly two million square feet of ISO- and IATF-certified manufacturing space and more than 2,400 employees worldwide. Its light guides serve demanding OEM applications, including automotive illumination, consumer electronics and medical devices.BRECKSVILLE, OH
LumighostLumighost takes architectural responsibility for regulated medical products, engineering them from custom hardware and embedded systems through connected applications and production readiness. Its engineer-to-engineer model emphasizes traceability, risk analysis, and manufacturing-oriented development for medical device programs, including robotic platforms and medical training systems. The company works across FDA, EU MDR, and other regulated environments, with NDA-based engagements available from the outset.
Eulum DesignFounded in Essex in 2005, Eulum Design develops bespoke lighting and electronic technology for lighting OEMs, carrying projects from concept and industrial development through batch production. Its in-house expertise is particularly visible in Casambi wireless controllers and in human-centric LED boards developed through work with the University of Surrey’s Sleep Research Centre and Harvard Medical School’s Division of Sleep Medicine. Eulum operates across the United Kingdom and the United States, where its electronic design center was co-founded in Doylestown, Pennsylvania, in 2008.PIPERSVILLE, PA
Peregrine Surgical LLCFounded in 1991, Peregrine Surgical LLC makes and develops single-use ophthalmic and vitreoretinal surgical devices for OEM and private-label partners. Its roots in fiber optics show in products such as illuminated laser probes and light pipes, while its in-house development and packaging services help medical-device companies move products from prototype to market. Peregrine performs product development to meet U.S. Code of Federal Regulations Title 21 and ISO 13485 requirements.NEW BRITAIN, PA