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  • ISO 13485

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    Meet medical industry and customer requirements
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    Business Challenge

    Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete internationally.



    Solution

    What is ISO 13485 certification?
    ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Based on ISO 9001, the emphasis on continual improvement is replaced with an emphasis on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices.


    Does ISO 13485 certification fulfill FDA requirements?
    No. It is important to note that being ISO 13485 certified does not fulfill the requirements of either the FDA or foreign regulations; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.

    Why Choose Bureau Veritas?

    • We perform a systematic, independent audit of the management system to identify strengths and areas for improvement.

    • We use a planned audit schedule to ensure the management system meets objectives and provides continual improvement in key areas.

    • Our extensive auditor network helps reduce auditor travel costs.

    • Certification from Bureau Veritas is recognized and well-respected globally.

    FAQ - Frequently Asked Questions
    What are the key benefits of ISO 13485?

    • Potentially gain entrance into international markets since certification to ISO 13485 is seen as a first step toward achieving compliance with European requirements.

    • Help protect your organization’s financial investment through harmonized quality management system requirements for regulatory purposes.

    • Create a framework for implementing a systematic approach to monitoring your organization’s processes and your customer’s feedback.

    Does ISO 13485 certification fulfill FDA requirements?
    No. It is important to note that being ISO 13485 certified does not fulfill the requirements of either the FDA or foreign regulations; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.

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