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instrumental. exceptional. global.

United States

A global company with operations in the U.S., Ireland and Mexico, Harmac Medical Product has been headquartered in Buffalo, N.Y since our company’s founding in 1981. Our strong commitment to quality ensures compliance to all specifications and our manufacturing team uses the latest in lean manufacturing techniques to ensure ongoing reliability in all locations.

Highlights of our U.S. facility include:

  • ISO Class 8 clean rooms
  • ISO Certified, FDA Registered and 21 CFR Part 11 and Part 820 Compliant ISO 9001:2008; ISO 13485:2003; ISO 13485:2012; ISO 14001:2004
  • CFR-11 compliant company-wide quality system.
  • Well established executive team and a highly skilled workforce of more than 400 employees.
  • Capabilities for in-house development of proprietary equipment, as well as manufacturing processes and techniques.
  • On-site equipment design and automation.