ISO13485

ISO 13485 is a quality system standard that is exclusive to the design, manufacturing and servicing of medical devices. Manufacturers may become certified to the standard by having an independent assessment of their quality system, by an ISO registrar or Notified Body. Notified Bodies are those registrars which are authorized by the European Economic Area (EEA), to perform work under the medical device directive. This can include issuing accredited quality systems registration.

We have extensive experience in developing and documenting quality systems which meet the requirements of ISO 13485. Our experience includes actual ISO 13485 assessments with Notified Bodies. We can also help you in transitioning you quality system to the new version of the ISO 13485 standard.

Key Benefits

    ISO 13485 Training, Audits and Gap Analysis.
    ISO 13485 Internal Auditor Training.
    Quality System Procedure Development and Implementation.
    How to Structure and Document Your Quality System.
    Mock ISO Assessments and Audits.