ISO13485
Creganna-Tactx 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-Tactx Medical include:
- Process Yield / Defect Analysis
- Formal Corrective / Preventive Action
- Training and Certification Programs
- Procedural Controls
- Material Traceability Systems
- Creganna-Tactx Medical can provide full biocompatability data for finished products
FDA
Creganna-Tactx Medical is an FDA registered contract manufacturer.
MHLW
Creganna-Tactx 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: campbell.customerquality@cregannatactx.com
Plymouth, MN: plymouth.customerquality@cregannatactx.com
Singapore: singapore.customerquality@cregannatactx.com
