Since its founding in 1968, Harmac Medical Products has grown from a maker of plastic medical components into a global contract manufacturer serving medical-device companies. The company now brings more than 1,200 employees together across four facilities in the United States, Ireland and Mexico, with a history of investing in its communities as well as its manufacturing operations. Harmac is ISO 13485 certified and supports customers from product development through large-scale production.
ISO 13485:2016
I.S. EN ISO 13485:2016
ISO 14644-1 Class 8 Cleanrooms
Compliance program
FDA Registered
Registration
21 CFR Part 820 Compliant
Compliance program
21 CFR Part 11 Compliant
Compliance program
FDA
Quality certification
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
DuPont™ Spectrum™ (Spectrum Plastics Group)DuPont™ Spectrum™ (Spectrum Plastics Group) is a medical device contract development and manufacturing organization that designs and produces components and finished devices, including medical tubing and catheters, for healthcare manufacturers. With 61 years of experience, 18 global locations, 1 million square feet of operations and more than 2,900 employees, the company supports programs from prototype through high-volume production. Its manufacturing network is certified to ISO 9001:2015 and ISO 13485:2016, with AS9100 certification and ITAR compliance supporting demanding medical and aerospace-related work.GLENS FALLS, NY
TecometTecomet is a contract manufacturer of medical-device products, with more than 50 years of experience in medical manufacturing and a history in the orthopedic implant market dating to 1970. It partners with medical companies from design and prototyping through full-scale production, with 24 manufacturing campuses across six countries and 3,500 employees reported on its homepage.BRISTOL, PA
SchivoPart of the Waterford, Ireland-based Schivo Group, Schivo is a global medical-device contract manufacturer known for vertically integrated production and unconventional problem-solving. Its ISO 13485-certified, FDA-registered facilities support medical-device OEMs from early prototypes through production, with particular experience in minimally invasive and robotic-assisted surgery. The wider group employs more than 630 people across 302,000 square feet of manufacturing space in Europe, North America, and Asia.PLAINVIEW, NY