October 17, 2016 – We’ve passed another milestone: we’ve obtained the first part of the CE certification.
The CE certification is the key needed to introduce a medical device on the market. In order to set our artificial pancreas on the market, we have been working in parallel to get two things certified:
- Inreda Diabetic (as a company). This means that we have documented and implemented a quality management system which includes all processes which are necessary to develop, manufacture, service and improve our artificial pancreas. This end-to-end control is necessary to ensure high quality medical devices and user safety.
- The actual device, the artificial pancreas we are developing. Among many things, this means that we are going to test the device’s usability with users, an external testhouse is going to perform technical tests, and clinical trials are performed (of which we’ve already completed one). Only once these aspects have been successfully passed, the device can be CE marked as it is officially safe and its effectiveness is measured and proved (e.g. blood glucose is more often in good range and hypoglycemic events happening less often).
But… from those two things, the first one is now officially completed!
Several certification inspections have been performed by DEKRA, an external and independent certification organization, which have led to a positive result. Inreda Diabetic is fully compliant with the EN ISO 13485:2012 and has been granted this ISO certificate. In other words, this officially entitles Inreda Diabetic to develop and manufacture artificial pancreas systems.
First box is ticked…
Thumbs up to all our partners (and colleagues who weren’t there for the photo)
We continue our work on the 2nd part: getting the CE for the artificial pancreas itself.