Products & Services

Compliance Navigator

A regulatory document management tool for medical device and IVD manufacturers to support regulatory compliance.

Access medical device and IVD standards, regulations and guidance documents to support market access and ongoing compliance across the EU, UK, US and MDSAP markets.

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

However, keeping up with new and updated standards and regulations across multiple markets is complex and time-consuming. Missing a critical update can result in delayed approvals, unexpected costs, product launch failures or even recalls.

Compliance Navigator is an online regulatory platform that helps medical device and IVD manufacturers quickly find and organize relevant standards and regulations. By providing timely updates and structured access to essential documents, Compliance Navigator enables teams to respond faster to regulatory changes, strengthen compliance processes and significantly reduce regulatory risk.

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Medical research scientist dropping a sample onto a slide while her colleague examines it under a microscope in a modern laboratory.

Why BSI

Medical device industry expertise you can trust

Built by BSI experts, Compliance Navigator is a trusted platform that helps medical device and IVD manufacturers access and manage the standards and regulations they depend on.

Download the Compliance Navigator brochure to explore how the platform supports medical device and IVD manufacturers in managing regulatory requirements. Learn how easy access to essential standards, regulations and guidance documents helps teams interpret requirements faster, streamline compliance activities and stay aligned with evolving regulatory expectations.

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Explore Compliance Navigator with our interactive product demo

Take a guided interactive tour and see how regulatory teams can quickly find and organize medical device and IVD standards, regulations and guidance.

Quickly find relevant standards and regulations using powerful search and filters.
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Understand regulatory updates faster with tracked changes and expert insight.
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Receive alerts when standards or regulations change, helping you stay compliant.
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Access essential medical device and IVD standards, regulations and guidance in one place.
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Bookmark key documents and add notes to track requirements across projects.
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Case Study

A Swiss manufacturer saves time and money staying ahead of regulations

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

At ELLA-CS in the Czech Republic, our tool saved time and supported 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

FAQs

Compliance Navigator Q&A

A concise Q&A guide on the features, benefits, pricing, access, and modules of Compliance Navigator.

Compliance Navigator is a standards management platform designed specifically for medical device and in-vitro diagnostic (IVD) manufacturers. It provides centralized access to thousands of standards, regulations, and guidance documents, helping teams manage compliance requirements across global markets.

The platform enables regulatory, quality, and product development teams to easily find, track, and interpret critical standards and regulatory documents needed to support medical device development and market access.
Compliance Navigator helps medical device companies maintain regulatory compliance by providing structured access to relevant standards, regulations, and guidance documents in one platform.

Key capabilities include:

Smart search to identify applicable standards quickly

Real-time notifications when standards or guidance documents change

Tracked changes to compare updated versions of standards

Expert commentary to help interpret complex regulatory requirements

Device-specific profiles that organize compliance requirements by product

These tools allow teams to stay informed about regulatory updates and respond proactively to changing compliance requirements.
Compliance Navigator provides access to a wide range of international medical device regulations, standards, and technical guidance.

Examples include:

EU Medical Device Regulation (MDR 2017/745)

EU In Vitro Diagnostic Regulation (IVDR 2017/746)

FDA medical device regulations, including the Code of Federal Regulations (CFR)

International standards such as ISO, IEC, BS, EN, ASTM, AAMI, and CLSI

The platform also includes supporting guidance documents such as MDCG guidance, implementing acts, and harmonized standards relevant to global medical device compliance.
Compliance Navigator includes automated notifications and monitoring tools that help users track updates to standards, regulations, and guidance documents.

Users receive alerts when:

Standards are revised or updated

New versions of documents are released

Upcoming regulatory changes are announced

The platform also includes tracked-changes versions of standards, allowing teams to clearly identify what has been modified between document revisions.
Yes. Compliance Navigator provides comprehensive access to regulatory content related to the EU Medical Device Regulation (MDR 2017/745) and EU In Vitro Diagnostic Regulation (IVDR 2017/746).

BSI Compliance Navigator can help medical device manufacturers understand and implement EU regulatory requirements more effectively.
Compliance Navigator supports regulatory affairs and quality teams by simplifying how they manage regulatory documentation and standards.

The platform enables teams to:

Organize standards by product or device type

Track regulatory updates across multiple markets

Conduct faster regulatory gap analysis

Interpret standards using expert commentary

Collaborate internally using bookmarks and annotations

This helps regulatory teams reduce time spent searching for documentation while improving compliance readiness.
Yes. Compliance Navigator includes powerful search and filtering tools that help users identify relevant standards based on device type, keywords, or regulatory topic.

Users can quickly locate the standards that apply to specific medical devices and organize them within device-specific profiles, ensuring teams always have the correct compliance requirements linked to each product.
Unlike general document management platforms, Compliance Navigator is built specifically with the needs of medical device and IVD manufacturers in mind. BSI has a dedicated team working on Compliance Navigator throughout the year to ensure the content set continually evolves to support the requirements of clients.
Compliance Navigator is designed for professionals responsible for regulatory compliance and product development within medical device organizations.

It includes:

Regulatory affairs specialists

Quality assurance professionals

Compliance managers

R&D and product development teams

Technical documentation and regulatory strategy teams

The platform is particularly valuable for organizations managing multiple devices across different regulatory markets.
Yes. Compliance Navigator is designed to support global regulatory compliance for medical device manufacturers operating in multiple markets.

The platform includes regulatory content covering:

Europe (MDR and IVDR)

UK (Regulations and guidance)

United States (Regulations and guidance)

MDSAP jurisdictions (Regulations and guidance for Canada, Japan, Brazil & Australia)

Additional regulatory indexes for Switzerland, and guidance documents for the WHO and IMDRF

This allows companies to manage regulatory requirements across global markets within one centralized system.
Compliance Navigator helps ensure compliance with key medical standards by giving users constant access to the latest versions and notifying them of any updates. It supports both pre audit preparation by enabling users to verify that their devices meet the specific requirements, and post certification monitoring to ensure ongoing compliance as regulations or standards change.
Regulatory content within Compliance Navigator is updated frequently to ensure users always have access to the most current standards and regulatory information.

This continuous update process helps manufacturers stay aware of regulatory changes and maintain compliance across evolving regulatory environments.
We have a tiered pricing structure that is based on revenue to ensure we’re able to support all companies regardless of size and resource. Request a quote below to receive a tailored quote from our team.

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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.

Whitepapers

Download healthcare regulatory and compliance whitepapers

Explore expert whitepapers covering medical device regulations, standards and compliance challenges to help your team stay informed.

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Blogs

Stay updated with the Compliance Navigator blog

Read expert insights on medical device regulations, standards updates and industry developments from the Compliance Navigator community.

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Free Trial

Start your Compliance Navigator free trial

Experience how Compliance Navigator helps regulatory teams access and manage standards and regulations more efficiently.

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Video

See Compliance Navigator in action

Watch our short video to learn how Compliance Navigator helps medical device teams manage regulatory requirements more effectively.

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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.

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