Creganna Medical’s design & manufacturing processes are fully accredited to ISO13485. We operate to the highest quality standards, as expected for the medical device industry. Quality measures utilized at Creganna Medical include:

  • Process Yield / Defect Analysis
  • Formal Corrective / Preventive Action
  • Training and Certification Programs
  • Procedural Controls
  • Material Traceability Systems
  • Creganna Medical can provide full biocompatability data for finished products


Creganna Medical is an FDA registered contract manufacturer.


Creganna Medical, Galway is accredited by Japan’s MHLW as an accredited foreign manufacturer, in accordance with article 13-3 of PAL.

For quality support please email the appropriate manufacturing site for your product:

Galway: CREG-GALCustomerQuality@te.com

Campbell, CA: customer.qualityca@creganna.com

Plymouth, MN: plymouth.customerquality@creganna.com

Singapore: singapore.customerquality@creganna.com


Quality Certificates (including ISO 13485)

Simply click to download the required certificate.


Latin America



Campbell, CA
San Jose, CA
Plymouth (Trenton L.), MN
Plymouth (LSA), MN
Tualatin, OR
Watertown, MA
Heredia, Costa Rica
San Rafael, Costa Rica
Galway, Ireland Singapore


Quality Policy

Download Quality Policy

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