We are proud to announce that we have been awarded ISO 13485 certification to design, develop, distribute and provide technical support of medical device software.
The medical device industry is one of the most heavily regulated industries in the world. ISO 13485 is an internationally agreed quality management standard that is designed to ensure regulatory compliance in development of software as a medical device. The rigorous standard is not easy to achieve, with most UK certifications belonging to medical device manufacturers or companies who provide software for manufacturers.
Our virtual care platform, Lenus Health, enables patient generated health data to be securely shared from apps, wearables and sensors as part of new, digitally enabled care pathways.
Developed in close collaboration with NHS Scotland, Lenus uses machine learning and wearable devices to enable remote patient monitoring, as well as supporting virtual consultations.
The ISO certification represents a key differentiator for Storm ID in how we design, build and support software for the health and care sector. The certification will be a key enabler in regulating our machine learning algorithms and digital services under medical device regulation.
Paul McGinness, Storm ID director
You can learn about Lenus Health here.