Since 1995, Middlefield, Ohio-based Troy Innovative Instruments has made precision-machined components and assemblies for medical, dental, defense and weapons applications. The company is particularly experienced with spinal implants and other tightly controlled medical components, while its integrated facility supports demanding defense and firearm work. Troy’s long-serving employees—including key shop-floor staff with more than 20 years at the company—work within ISO 13485- and ISO 9001-registered quality systems, with ITAR and FDA registration.
ISO 9001
ISO 13485
ITAR
Registration
US-Canada Joint Certification Program
Registration
FDA
Compliance program
21 CFR 820
Compliance program
Infinite Medical SolutionsBuilt on more than 40 years of experience, Infinite Medical Solutions manufactures precision orthopedic and trauma implants and manages their engineering, processing, and assembly in Eastlake, Ohio. Its 200,000-square-foot facility on 14 acres is set up to scale complex medical-device projects, from spinal implant assemblies to micro-machined suture buttons. The company’s quality systems comply with ISO 9001, ISO 13485, and AS9100, reflecting its roots in aerospace as well as medical manufacturing.EASTLAKE, OH
Flex-Cell Precision, IncFor more than 30 years, Lancaster-based Flex-Cell Precision has produced micron-tolerance CNC-machined and milled components for medical, aerospace, and defense applications. Its automated shop can run up to 12 CNC mills around the clock in a robotic cell, while dedicated PEEK machining supports implantable medical devices. Flex-Cell is ISO 9001:2015 and ISO 13485:2016 certified, FDA registered, and ITAR registered.332710LANCASTER, PA
Acero Precision, IncKnown for its fast, exacting work in medical manufacturing, Acero Precision produces complex machined components for customers whose parts must perform reliably in demanding applications. The West Chester company operates a 100,000-square-foot facility with 40 CNC machines, and its medical business—focused especially on spine instrumentation—accounts for nearly 80% of its work. Acero maintains ISO 9001 and ISO 13485 certifications, with the latter held for 12 consecutive years.WEST CHESTER, PA
Norman Noble, IncFounded in Cleveland in 1946, Norman Noble manufactures precision medical implants and device components, with particular expertise in nitinol micromachining and laser processing. The company has grown from a garage operation into a six-facility manufacturer with more than 750 employees and over 280,000 square feet of production space, supporting projects from rapid prototype through commercialization. Norman Noble’s proprietary STEALTH athermal laser technology and vertically integrated finishing capabilities are backed by an ISO 13485:2016-registered quality system and more than 1,700 process validations for Class II and III devices.CLEVELAND, OH