Quality

ISO13485

Creganna’s manufacturing processes are fully accredited to ISO13485.
We operate to the highest quality standards, as expected for the medical device industry.

Quality measures utilised at Creganna include:

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

For customer quality support please email: customerquality@creganna.com

Download Quality Certificate
 

FDA

Creganna is an FDA registered contract manufacturer.
 

MHLW

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