Depending on the environment of our organization, our needs, our objectives, our processes and the regulatory requirements applicable to the activities of PAMA Manufacturing and Sterilization, we have updated our quality management system so that we are MDSAP compliant. On April 12, 2021, we officially obtained our ISO 13485: 2016 certification.
See our certification
In addition, we have started our own ethylene oxide sterilization service within our company. The latter conforms to the ISO 11135: 2014 standard. We are now available to meet the need for sterilization of medical devices by contract.
HENCE
This international standard is applicable to:
The manufacture of sterile and non-sterile products used in the medical sector and subcontractor, for customers operating in the medical field;
Ethylene oxide sterilization under contract.