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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
  • FDA Registered and 21 CFR Part 820 Compliant, Certified to ISO 13485:2016 and ISO 14001:2015
  • 21 CFR Part 11 compliant company-wide quality management 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
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