Elcam Medical is a world class producer of precision injection-molded disposable medical devices, and a provider of innovative solutions for specialized flow control needs. Elcam supplies its products to the medical industry's leading companies, and today is the premier provider of stopcocks and manifolds to the US and European OEM markets.
Elcam meets or exceeds all of the medical industry quality standards. Development, manufacturing, warehousing, documentation and traceability meet FDA's Quality Systems Regulation Title 21 CFR Part 820, and the European Directive 93/42/EEC
Elcam's Quality Management System is ISO 13485 (2003) certified.
Elcam has been successfully audited by the FDA , and has successfully passed an audit by the European notified body. Many of our products products have earned the prestigious CE Mark and are 510(k) cleared.
Fralock (ISO 13485) provides design, development, and manufacturing services for the medical, diagnostic, and life science industries utilizing precision technologies (laser, rotary die-cut, lamination, CNC machining). Whether it is prototype or production volumes, the company offers solutions...