Based on applicable standards, in particular EN 60601-1 and IEC 62304, Cisteo MEDICAL takes charge of the electronic and software development of your medical device.
Thanks to our combined skills in electronics, embedded systems and software, as well as mechanical engineering, we can handle both software and hardware.
Integrated skills :
We quickly integrate mock-ups to confront our solutions with reality, enabling projects to be rapidly oriented towards appropriate technologies, thus ensuring product performance and patient safety.
We can also work with our subcontractors and partners to carry out electrical safety verification and validation phases, as well as electromagnetic compatibility (EMC) verification, customantenna definition and custom battery design.
Software and embedded software are designed according to the IEC 62304 development process:
The team's skills are focused on the following applications:
We work on all medical devices up to class III. Our expertise applies to :
Our ISO 13485 certification now includes this know-how. Already available within Cisteo MEDICAL, these services are at the heart of the solutions we aim to bring to medtech start-ups.
We integrate all the steps involved in accelerating the development of your DM:
In order to simplify the development of your medical device, we have integrated all our skills:
And to guarantee the conformity of your product, our services are carried out in compliance with the applicable standards: