Using the applicable standards and in particular the EN 60601-1 and IEC 62304, Cisteo MEDICAL takes care of the electronic and software development of your medical device.
Thanks to the collaboration of the electronics, embedded systems software, but also mechanics skilled engineers, we can take care of the software part but also the hardware development part.
Electronic development
Integrated skills in house:
- Design of multilayer electronic boards: flexible, rigid or hybrid PCBs
- Implementation of microcontrollers
- Wireless communication (Bluetooth, etc.)
- Battery and rechargeable battery management
- Acquisition of sensor signals
- Motor control
- Electronic and mechanical co-design ECAD/MCAD co-design
- Mechatronic design of test benches
- Electronic card design with Altium
We quickly manufacture the mock-up to compare our solutions to reality, thus making it possible to quickly direct projects towards suitable technologies and thus ensuring product performance and patient safety.
We can also support you, with our subcontractors and partners for carrying out the verification and validation phases of electrical safety but also for the verification of electromagnetic compatibility (EMC), the definition of custom-made antenna or even the design of custom-made battery.
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Software development
The software and embedded software are designed based on the development process of the IEC 62304 standard:
- Design
- Documentation
- Tests and validations
- Maintenance
The team's skills are oriented around the following applications:
- Software development (PC, smartphone, tablet, etc.)
- Embedded software development (microcontroller, FPGA, IOT)
- HCI integration according to customer graphic charter
- Software development for test bench
- Mobile application development
Electro-Medical devices and active implantable devices
We work on all class of medical devices with a huge appetite for class III. Our expertise applies to:
- Active implantable devices
- Electro-medical devices
- Mobile apps
- Test benches
Our ISO 13485 certification field now integrates this know-how. Already existing in Cisteo MEDICAL, these services are at the heart of the solutions that we wish to provide to Medtech start-ups.
One-stop-shop service provider, specialized in medical devices
We integrate in house all the steps to accelerate the development of your DM in compliance with the actual regulatory requirements :
- Feasibility and design
- Proof of concept (POC) and prototypes
- Small series for preclinical and clinical verification and validation
- Large series manufacturing after industrialization
To simplify the development of your medical device, we have integrated all of the skills in:
- Mechanical
- Electronic
- Software
And in order to guarantee the conformity of your product, our services are carried out according to the applicable standards:
- MDR 2017/745
- IEC 62304
- 60601-1 standards (and collateral standards)