CE approval for Thermosaver Rescue Bag

The collaboration with Thermosaver started at the end of Q2-21 by establishing the regulatory strategy and pathway to CE approval. Now after a little over 6 months of dedicated and comprehensive work by the team we are very pleased to announce that the Thermosaver rescue bag is CE approved and Thermosaver AS has an MDR compliant technical file and QMS.

The product is a medical device Class I product and for Thermosaver the CE mark is a recognition of safety, quality, and compliance.

The journey has been intense, challenging, and fun. It’s great working with committed people and the collaboration with Thermosaver and other partners in this project has been great.

The process has been challenging and demanding and we would never pull this off without the superb support from Yallow. Now we are ready for market introduction as a medical device.