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