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Products & Services

Compliance Navigator

Transforming how medical device and IVD device manufacturers manage their regulatory documents to save time, maximise 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.

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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 digitalised and user friendly platform suitable for large multinationals and SMEs with single or multiple devices.

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

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

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

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

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

  • 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 Read more
Case Study

Our tool hasn’t just saved time at ELLA-CS – 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 Read more
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