Software as a Medical Device
Do you need Software as a Medical
Device capable of processing large
amounts of differential data from
medical images and more?
You can create your dedicated solution
with our specialists.
Why us
- Our QMS complies with ISO 13485, as shown by the Certificate for the Management System in accordance with ISO 13485:2016.
- During the project we create documentation in accordance with medical standards wich will support and accelerate the certification process of your solution in the future.
- We have worked out the software development lifecycle.
- Knowing the ISO 14971 standard and being able to develop healthcare software solutions that abide by the IEC 62304 standard .
- Our process of Software as a Medical Device development has been adjusted to ISO/IEC 27001 because we know data security’s importance in the medical device industry.
- We have experience in creating software that complies with CE and FDA.
Software development lifecycle
- Pre-project phase – this is the phase where idea for the project is born. General user requirements are gathered.
- Proof of concept phase – proving that the concept is viable and it will be possible to build the product around the idea. It includes determining scientific methods, developing initial solution, etc.
- Project summary phase – making sure that all activities are completed and finalized, any approvals are obtained etc.
- Feasibility phase – this phase allows for determination whether project is likely to be feasible from technical perspective.
- Development phase – this is the main product development phase when it comes to software. We make use of Agile methodologies and practices to ensure effective software development.
- Maintenance – our support after the end of the project.
Learn more about our competences
Risk management in medical devices, especially in software as a medical device.
IT provider with ISO 13485 – is it really crucial?
ISO 13485 certification – how to prepare?
