Hedy Canada is committed to providing customers with the highest quality products while ensuring safety and protection. We achieve consistent high quality by producing and distributing products under the control of our registered International Organization for Standardization (ISO) quality assurance system. All Hedy Canada products comply with Health Canada regulations and licensing.

Hedy Canada quality begins with each product’s specifications. For any single parameter, such as strength, elongation, acceptable quality level, and protein levels, there are a number of different standards throughout the world, including those set by ISO, American Society for Testing of Materials (ASTM) and Canadian General Standards Board (CGSB). Hedy Canada requires that our products meet or exceed the most demanding of the standards listed above.

Registrations

Health Canada classifies all medical devices based on risk assessment. Briefly, these classifications are:

CLASS I: Non-Invasive Devices
CLASS II: Invasive Devices – Any device in which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
CLASS III: Devices intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion, or active devices intended to emit ionizing radiation.
CLASS IV: Devices intended for disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation, or a product produced through the use of DNA technology. Complete Health Canada regulations can be found at www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php. Hedy Canada products are classified as either CLASS I or II.

International Organization for Standardization (ISO) - ISO is a non-governmental network of the national standards institutes of 153 countries. They agree on specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis, in terminology and in the provision of services. Conformity of products and services to International Standards provides assurance about their quality, safety and reliability.

Health Canada's Therapeutic Products Branch (TPB) -All medical devices in Class II, III and IV must be registered with TPB. Products not registered are not to be sold for medical use in Canada. The medical devices active license listing is found at www.mdall.ca

American Society for Testing and Materials (ASTM) – This is a voluntary organization that creates technical standards for materials, products, systems, and services.

Manufacturing & Quality Control Processes

Hedy Canada products are manufactured in accordance with our demanding quality standards. All Hedy Canada CLASS II products are manufactured by organizations who maintain International Standards Organization (ISO) certificates appropriate for their facility. These quality systems are verified annually by an accredited third party registration organisation.