Locations

Unrivaled Medical Device Manufacturing Capabilities Across the Globe.

Since our founding in 1981, we have expanded into two additional manufacturing facilities – the first in Castlerea, Ireland in 1998 and the second in Tijuana, Mexico in 1999 – establishing Harmac as a world-class, global manufacturer.

Our global footprint means that we can help customers around the world access the knowledge, expertise and value engineering capabilities available at each location – to provide fast turnaround times, innovative solutions and quality products.

Core Features at Each Facility:

United States

Ireland

Mexico
ISO Class 8 Clean Rooms
FDA Registered
21 CFR Part 820 Compliant
21 CFR Part 11 Compliant
ISO 13485 Certified
Well established executive team
PMA, 510K & CE Marked Devices
Workforce of at least 300 employees
ISO 14001 Certified

United States
- ISO Class 8 Clean Rooms
- FDA Registered
- 21 CFR Part 820 Compliant
- 21 CFR Part 11 Compliant
- ISO 13485 Certified
- Well established executive team
- PMA, 510K & CE Marked Devices
- Workforce of at least 300 employees
- ISO 14001 Certified

Ireland
- ISO Class 8 Clean Rooms
- FDA Registered
- 21 CFR Part 820 Compliant
- 21 CFR Part 11 Compliant
- ISO 13485 Certified
- Well established executive team
- PMA, 510K & CE Marked Devices
- Workforce of at least 300 employees
- ISO 14001 Certified

Mexico
- ISO Class 8 Clean Rooms
- FDA Registered
- 21 CFR Part 820 Compliant
- 21 CFR Part 11 Compliant
- ISO 13485 Certified
- Well established executive team
- PMA, 510K & CE Marked Devices
- Workforce of at least 300 employees

Let’s Discuss Your Needs

Unrivaled Medical Device Manufacturing Capabilities Across the Globe.

Core Features at Each Facility:

ISO Class 8 Clean Rooms

FDA Registered

21 CFR Part 820 Compliant

21 CFR Part 11 Compliant

ISO 13485 Certified

Well established executive team

PMA, 510K & CE Marked Devices

Workforce of at least 300 employees

ISO 14001 Certified

United States

ISO Class 8 Clean Rooms

FDA Registered

21 CFR Part 820 Compliant

21 CFR Part 11 Compliant

ISO 13485 Certified

Well established executive team

PMA, 510K & CE Marked Devices

Workforce of at least 300 employees

ISO 14001 Certified

Ireland

ISO Class 8 Clean Rooms

FDA Registered

21 CFR Part 820 Compliant

21 CFR Part 11 Compliant

ISO 13485 Certified

Well established executive team

PMA, 510K & CE Marked Devices

Workforce of at least 300 employees

ISO 14001 Certified

Mexico

ISO Class 8 Clean Rooms

FDA Registered

21 CFR Part 820 Compliant

21 CFR Part 11 Compliant

ISO 13485 Certified

Well established executive team

PMA, 510K & CE Marked Devices

Workforce of at least 300 employees