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.
- 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.