Part 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.
ISO 13485
certification
FDA Registration
registration
ISO 9001
certification
ISO Class 7 Cleanroom
certification
ISO Class 8 Cleanroom
certification
Harmac Medical ProductsSince 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.BUFFALO, NY
CadenceCadence is a full-service medical device contract manufacturer that takes complex products from early design through finished-device production and supply chain management. With approximately 800 employees and locations across the United States and Costa Rica, the company combines vertically integrated manufacturing with particular expertise in difficult-to-machine components and miniature medical parts. Cadence operates FDA-registered, cGMP-compliant facilities and maintains ISO 13485 certification, including certified ISO Class 7 cleanrooms for demanding assembly work.CRANBERRY TOWNSHIP, PA
Acrotec MedtechAcrotec Medtech is a Swiss-rooted collective of precision manufacturers built to work as one medical-manufacturing partner for OEMs. Its network spans more than 1,000 employees and 10-plus locations, combining the close technical collaboration of specialist shops with global production scale. The group’s companies are ISO 13485 certified and FDA-registered.WARMINSTER, 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