Quality

ISO13485

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

FDA

Creganna Medical is an FDA registered contract manufacturer.

MHLW

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: customerquality@creganna.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.

US

Latin America

Europe

Asia

Campbell, CA
San Jose, CA
Plymouth (Trenton L.), MN
Plymouth (LSA), MN
Eden Prairie, MN
Tualatin, OR, US
Heredia, Costa Rica Galway, Ireland Singapore

 

Quality Policy

Download Quality Policy

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