Lumighost 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.
HIPAA-Aligned Data Handling
Compliance program
FDA Design Control Alignment
Compliance program
EU MDR & CE Framework Familiarity
Compliance program
ISO 9001:2015 Alignment
Compliance program
ISO 13485:2016 Awareness
Compliance program
FDADESIGNCONTROLS
Quality certification
CE
Quality certification
Lumitex, LLCBorn 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.BRECKSVILLE, OH
ARCH Medical SolutionsARCH Medical Solutions brings together a nationwide network of FDA-registered facilities to contract-manufacture tight-tolerance medical implants, instruments, and components for OEMs. Its precision work spans orthopedic devices and surgical-robotics parts, with engineering support and prototype-through-production services built into the process. The company also develops MedTorque silicone-handled surgical instruments and operates under ISO 13485-certified quality systems.QUAKERTOWN, PA
Paragon MedicalParagon Medical brings more than a century of combined medical-manufacturing expertise to its work as a global contract design and manufacturing organization for medical-device companies. Its vertically integrated operations support customers from product development through commercialization, with ISO 13485:2016-compliant facilities across its worldwide network.DAYTON, OH
Marsh MedicalMarsh Medical makes engineered components for critical medical devices, pairing in-house engineers and chemists with U.S.-based manufacturing to develop custom pressure-control and sensing solutions. The division draws on more than four decades of medical-component experience and the 125-year history of its Marsh Bellofram parent company, giving manufacturers a single source for both standard and hard-to-recreate parts. Its products are produced and tested under in-house procedures, with Marsh Medical certified to ISO 9001:2015.NEWELL, WV