Helping Relu to comply with changing regulations

Relu

Regulatory Affairs

Medical Devices

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About Relu

Relu is a software company that developed the “Virtual Patient Creator” application to automatically segment 3D medical images using artificial intelligence (AI). Basically, they are automating the planning of dental treatments.

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Challenge

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Approach

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Result

How to comply with changing regulations

In order to keep up with constantly changing regulations, Relu needed a partner with sufficient expertise and knowledge of new technologies to fill the knowledge gap they were experiencing. Relu knows how to make a good product, but regulations are a whole other ball game.

They wanted a CE mark on their device, which means they needed technical documentation. That way, the competent authorities can approve their product for marketing.

Step-by-step approach

For this regulatory journey, the QbD Group used a hands-on and step-by-step approach:

1. Understanding Relu’s way of working
2. Making sure the expectations are clear
3. Communicating clearly during the writing of the technical documentation

Result

Processes optimized for future growth

By understanding Relu’s way of working, combined with QbD’s expertise in compliance, new processes were established that fit perfectly with their daily operations and are ready for future growth.

Get in touch

Do you need help complying with changing regulations?

Discover how our RA experts can help you, or contact us directly. We’d be happy to assist you!

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