Quality and Standards

Oridion is committed to provide its customers with instruments that exceed their basic requirements and their quality expectations. Oridion employees are trained to be aware of the life support applications of our instruments and how the end user’s expectations, of our product quality, are part of their medical practice.

It is the policy of Oridion to meet the specific requirements of international standards that have been established for the development, manufacturing, sales and service of medical equipment. As part of this policy, all medical devices and components produced by Oridion are designed and manufactured in accordance with:

• ISO 13485:2003
  An International Quality System Standard for the design and development, production and servicing of medical devices, that is the basis for the Oridion Quality System.
• USA Code of Federal Regulations 21CFR820, Quality System Requirements (QSR) for Medical Devices
  The American Food and Drug Administration (FDA) regulation that covers the design, manufacturing and marketing of medical devices in the United States.
• Medical Device Directive (MDD) 93/42/EEC
  The European Standards detailing the requirements for medical devices to receive the CE Mark.
• Canadian Medical Device Regulation P.C 1998-783 7 May, 1998
  The Canadian Health Authority Regulations
• Japanese Pharmaceutical Affairs Law
• ISO 14001:2004
  The international standard for managing the environmental aspects of Oridion processes, products and services.

Adhering to this policy will ensure that our customers receive products that meet their requirements at a consistently high level of quality and reliability. Consistent with this policy, Oridion has prepared and implemented a Quality System compliance program.

Oridion continuously works to improve its processes and products and towards this goal uses the Six Sigma methodology.