Within the framework of the PTTI initiative, CRITICAL Software has successfully concluded a feasibility study, which shows how certification methodologies used for space systems can be adapted to be highly-effective in the certification of Medical Devices.
The cost and complexity of certifying a device as a Medical Device is enormous. Large Medical Devices’ companies can be up to date with applicable standards, and have the financial capability to invest large amounts of money in product certification. Smaller companies, very often start-ups with state-of-the-art disruptive technologies must invest instead in product development, which has the potential of creating large time-to-market cycles if the necessary certification process is not followed as it should.
Through this project, CRITICAL Software demonstrated the feasibility of applying mature qualification and certification methodologies, originating in the ECSS standards (being used by ESA for a long time) in the field of embedded Medical Device systems. Partnering with Perceive3D as end-client, CRITICAL Software applied some of these techniques in the early-stages of the certification process of RDFixer, a disruptive technology that allows real-time correction of the radial distortion in endoscopic images.
With the successful completion of this project, CRITICAL Software is now actively pursuing new opportunities for the application of highly-efficient certification methodologies for other companies operating in the Medical Devices field.
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