Holds Certificate No: FM 704391
Effective Date: 2017-11-07
Expiry Date: 2020-11-06

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope:

Design, manufacture, sterilization and distribution of Perfusion and Critical Care Assemblies.

Holds Certificate No: FM 704391
Effective Date: 2020-11-07
Expiry Date: 2022-11-06

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope:

Design, manufacture, sterilization and distribution of Perfusion and Critical Care Assemblies.

Holds Certificate No: MDSAP 699520
Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the following criteria: ISO 13485:2016 and Canada – Medical Devices Regulations – Part 1 – SOR 98/282; USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

Design, manufacture, sterilization and distribution of Perfusion and Critical Care Assemblies.