ISO 13485:2003 Medical Device – Quality Management Systems

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

Should you be considering certification to this Standard please contact us for information, highly competitive quotes and directly approachable references.