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Quality and regulations

PAMA Manufacturing and Sterilization is committed to manufacturing safe, high quality medical devices to provide products and services that meet or exceed the needs of its customers, in accordance with applicable international regulations and its quality management system. Discover our certifications and licenses.

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Certifications

  • Cleanrooms and associated controlled environments - Part 1: Classification of particulate air cleanliness: ISO 14644-1: 2015 Class 7

  • Medical devices - Quality management systems - Requirements for regulatory purposes: MDSAP ISO 13485: 2016

  • Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices: ISO 11135: 2014 (Complies)

  • Quality System Regulation - 21 CFR Part 820 (Compliant)

 
 
Pama manufacturing and sterilization

Licenses

  • Establishment license for medical device, Health Canada: 3959

  • DEL (Drug Establishment Licenses): 102257-A

  • GS1 Canada: 7540290