Tecomet 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.
ISO 13485
ISO 14001
ISO 9001
AS9100
CMDCAS – Canadian Medical Devices Conformity Assessment System
PAL – Japanese Pharmaceutical Affairs Law Article 13-3
Registration
FMA – Japan Foreign Manufacturer Accreditation
Registration
Nadcap – Special Process Accreditations
U.S. Food and Drug Administration regulations (FDA)
Compliance program
PAL
Quality certification
FMA
Quality 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
SpiTrex OrthopedicsSpiTrex Orthopedics grew from Mediliant, which began with a management buyout in 2014 and later expanded through partnerships and acquisitions in the United States and Europe. Today, it serves medical-device companies as a contract manufacturer focused on bringing orthopedic implants and instruments from concept through commercialization. Its global facilities are ISO 13485-certified and FDA registered.LANCASTER, 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
Pulse Technologies, IncSince 1993, Pulse Technologies has grown from a precision contract manufacturer into a 250-person engineering and manufacturing company focused on medical devices. Its Quakertown team is known for developing proprietary surface technologies alongside the production of components for implantable devices, while also supporting aerospace and defense customers. Pulse operates from a 70,000-square-foot facility and maintains ISO 13485:2016, ISO 9001:2015 and AS9100D certifications.332710QUAKERTOWN, PA