As we continue reflecting on 2024, we’re pleased to share another significant achievement—obtaining CB certification for our lung monitoring device, Neola®. This certification confirms that Neola® meets specific quality requirements and international standards for medical devices in healthcare, with particularly high demands on safety, essential performance, and electromagnetic compatibility. The certificate is internationally recognized in about 50 countries and will form the basis for meeting the FDA’s regulatory requirements.
In this video interview, Sara Bergsten, CTO at Neola Medical, shares more about the acquired CB certificate in the BioStock Studio. Watch it here (in Swedish):