Pama manufacturing et sterilization

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.

Salle blanche

Certifications

  • Clean rooms 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: PAUUM ISO 13485: 2016 (Expected Q1 2021)

 

  • 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 (Expected Q1 2021)

 

  • Quality system regulations - 21 CFR Part 820 (Expected Q1 2021)

 
 
Pama manufacturing and sterilization

Licenses

  • Medical Device Establishment License, Health Canada: 3959

  • DEL (Drug Establishment Licenses) (Note: The request is being evaluated by Health Canada)

  • GS1 Canada: 7540290

12760, boul. Henri - Fabre

Mirabel, Quebec, Canada, J7N 0A6

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