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  • ISO 13485

    ISO 13485:2003 is a quality system standard designed specifically for medical device companies.....more

  • ISO 9001

    The standards provide guidance and tools for companies and organizations who want toensure...more

  • Medical
    Device

    uality Workforce recognizes the importance of timely product approvalsProduct delays can affect ...more

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New ISO 13485: Device Companies Have Three Years to Transition

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements Read More

faq-mdr-rim-eng

This document is an unofficial summary of the Regulations. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.Read More

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