Less risk, faster time to market: how Compliance Navigator is streamlining medical device compliance

They say that good design is obvious, but great design is invisible. BSI’s Compliance Navigator for Medical Device and In Vitro Device (IVD) is a good example of that. Information that was previously spread across multiple locations is stitched together seamlessly so you’ll barely notice the joins – you’ll only notice that compliance processes are smoother and faster.

The platform brings together information about regulations and standards to a single place, helping you to save time and ensure you interpret provisions correctly.

Complex compliance made easier

There’s clearly no room for error in medical device and IVD standards and compliance. Accuracy is all-important but achieving clarity on what is required may involve many hours spent tracking down standards and compliance information.

You’ll also need to keep track of recent changes to complex regulatory information, while managing your information across multiple fiddly documents and spreadsheets.

Traditionally, the result has been a significant administrative time and cost sink, and a slower time to market for medical devices. In a fiercely competitive marketplace, the cumulative effect of delays in navigating compliance frameworks can impact ROI and market performance.

BSI’s Compliance Navigator offers a streamlined digital platform to make regulatory document management and compliance easier.

Thousands of documents in one place

Compliance Navigator puts all the information you need in one place. Over 6,000 documents that are essential to medical device and IVD compliance are available on the platform. This sounds simple, but the finer details of how the system works show why this is an important development.

For instance, the standards landscape is dynamic and constantly changing. The platform offers the most up-to-date version of a standard, but it also goes one step further in alerting users to changes in standards. The track changes feature highlights which sections of a standard have changed, saving the need to cross-reference withdrawn and current standards.

Smart support and expert commentaries

In some cases, Compliance Navigator also provides guidance and interpretation to help smooth the transition to revised standards. Smart Support and expert commentaries are available to help you avoid making costly and time-consuming errors in interpretation.

The system allows for the creation of profiles and templates, so that users can create shortcuts to the information they use most often. This includes links to relevant content outside of Compliance Navigator.

Multi-user access

Compliance is often the responsibility of a team rather than an individual, which is why the Compliance Navigator allows multi-user access to facilitate teamworking. This feature is open to teams around the world, essential with today’s flexible working patterns.

Five key benefits of using Compliance Navigator

A new way of arranging the same information can radically change the way users approach it. Compliance Navigator has been designed with this in mind, helping users find information more quickly, while reducing the likelihood of errors. Key benefits include:

• Risk reduction - you’ll know about forthcoming changes to medical device changes, giving you time to adapt
• Support with interpretation - working out how to apply standards is fast and easy when you have expert commentary to clarify and explain it
• Time saving - user-friendly profiles save you valuable time in accessing information, with all relevant documents kept in the same place
• Ease of identification - an advanced search function helps you find relevant standards and regulatory documents in sections
• At-a-glance information - no more digging through news updates to find relevant changes

How Compliance Navigator has already helped users

Users have told us that Compliance Navigator has made a substantial difference to the way they approach compliance. Our case studies explain how the system has benefitted a variety of users, for example:

• An overstretched small compliance team at Robinson Healthcare approached standards on an ad-hoc basis, often wasting money on irrelevant standards and struggling to keep up with change. Introducing Compliance Navigator gave the team immediate access to up-to-date standards, helping to save time and money.
• Swiss medical device company SpineWelding AG wanted to introduce its innovative products into new markets, but found it hard to keep up with regulatory developments. Compliance Navigator’s regular updates and highlighting of changes in a document has made the process much easier.
• Medical Device company IceCure was wasting significant time manually tracking regulatory changes, reducing the resource available for more productive work. Compliance Navigator has made it easier for the Israeli company to access current standards and avoid errors.
• Delays in bringing a product to the market are costly for healthcare and logistics company Hologic, but the rate of change to medical device regulation was a major barrier to rapid delivery. Being able to anticipate changes more easily helped the team to prepare, saving precious time and money.

Why not get in touch to learn more and try Compliance Navigator for free?