Within Europe and Canada any manufacturer of a medical device classified as class 2A and above, must have an accreditation to ISO13485:2003. This also applies to manufacturers exporting medical devices under their own name to these areas and allows such companies to obtain the CE Mark and CMDCAS certification.

ISO 13485:2003 is the internationally accepted standard for medical device manufacturers and distributors world wide.

Where "custom made" medical devices are concerned there is no such requirement other than local self-certification to a Quality Management System. However, there is increasing pressure for a more stringent approach requiring certification by an accredited external body.

In principle the Standard is specific to medical devices as defined above and supplements ISO 9001:2000 with additional requirements including environmental controls, special processes, traceability, record retention and regulations which are critical to the medical device industry.

Lawrence-Hall have a considerable depth of experience in development, implementation and management of ISO 13485:2003 systems (both previous and revised standards) in the U.K., Europe, North America, Canada, the Middle East and Asia