½ûÂþÌìÌÃ

Contact Us
Search Icon

Suggested region and language based on your location

    Your current region and language

    A person using a tablet
    Products & Services

    Compliance Navigator

    Transforming how medical device and IVD device manufacturers manage their regulatory documents to save time, maximize resources and reduce risk.

    Access internationally recognised standards, regulations and guidance documents to support market access and continuous compliance in the EU, UK and MDSAP Countries

    For medical device manufacturers ensuring compliance with regulations in different jurisdictions is essential in order to place their products on the market.

    However, keeping abreast of new and updated standards and regulations is complex and time-consuming – and an error can result in failure to launch, unforeseen costs, delays and even product recalls.

    Compliance Navigator is an online tool that helps manufacturers discover, organize and respond quickly to changes in the regulatory landscape and mitigate these risks.

    People having a discussion holding clipboards
    Why BSI

    Medical device industry expertise you can trust

    Compliance Navigator is the only platform built by experts that puts device manufacturers regulatory and standards needs at the heart of the solution.

    Find out how your business can integrate Compliance Navigator into your existing processes quickly, and begin interpreting and implementing regulations, standards and guidance with greater ease and improved efficiency.

    Streamline your document management process today for greater efficiency

    Compliance Navigator is a fully digitalized and user friendly platform suitable for large multinationals and SMEs with single or multiple devices.

    • down arrow

      Get unrestricted access to an evolving set of regulations and standards.

    • home

      Search by device or keyword to find every relevant standard for your product portfolio in seconds.

    • plus

      Save time performing gap assessments with expert commentary on changes to documents relevant to you.

    • tick

      Reduce the risk of recall with real-time notifications direct to your inbox about document changes.

    • Icon description

      Streamline compliance processes with a user-friendly platform that's accessible to your entire team.

    • Icon description

      Organize, co-ordinate and manage user's access to documents with increased speed and efficiency.

    Case Study

    Our tool saves money and makes regulatory document management easy

    Client overview:

    SpineWelding AG is a medical device company that develops implant solutions for the human spine, using the patent-protected BoneWelding technology.

    ¡°Our process is now more connected to upcoming regulations than ever before, which saves us time and money and stops us going in the wrong direction.¡±

    Felix Kraeft Head of Quality and Regulatory Affairs
    Case Study

    Our tool hasn¡¯t just saved time at ELLA-CS ¨C it¡¯s helped its very survival

    Client overview:

    ELLA-CS develops and manufactures a range of medical devices. The company is the sole manufacturer of several globally unique healthcare devices.

    ¡°We have EU MDR standards coming into force. This has taken us hundreds of hours. Without Compliance Navigator it would have been far, far more.¡±

    Oldrich Benes CEO & Acting Director of Regulatory Affairs, ELLA-CS
    Compliance Navigator

    Take proactive steps towards compliance with Compliance Navigator

    Work smarter with an online platform designed by regulatory experts to help you stay up to date with medtech regulatory requirements across UK and EU.

    Contact Us

    Speak to the Compliance Navigator team today

    Transform your document management process and stay ahead of medtech regulatory updates. Talk with our experts today and arrange a free trial.

    Get in touch