Creavo Vitalscan, Corsens

Project Info

Case Study

Creavo Medical
During our founder’s employment period with Creavo, the two major projects achieved significant milestones.
Firstly, there was the Creavo Vitalscan, the first-generation Magnetocardiography Medical Device.
During the course of the project the following goals were achieved:
– Complete IEC62304- compliant SDLC creation
– SDLC integration with ISO13485-certified QMS
– Development of a complete set of documentation needed for FDA software certification to Class B.
– Successful FDA certification 510(k)
The second device from Creavo is called Corsens and is built up on the success of the Vitalscan, making it
better, easier to use and more advanced in terms of its diagnostic capabilities. The following goals were
– Creation of new system architecture
– Design of a complete set documentation needed for CE marking and FDA certification
– Design and development of the Embedded Software in accordance with Class B requirements
– ISO14971-compliant software risk management
– Overall software project management
With these significant achievements there is no doubt that Creavo will be able to finalise the
development of the Corsens platform and gain significant market share on the Magnetocardiography
market. Their development will be continuing to help Emergency Departments to rapidly rule out
patients with non-heart related conditions, thus accelerating the provision of the healthcare.

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