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Helping Relu to comply with changing regulations
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About Relu
Challenge
Approach
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:
- Understanding Relu’s way of working
- Making sure the expectations are clear
- 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!
