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: 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 certificates
https://www.te.com/global-en/industries/medical-healthcare/medical-resources/quality.html
