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.
A group pf scientists is analyzing medical data visible on computer screens

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

Risk management in medical devices, especially in software as a medical device.

gralight imaging iso 13485 medical compliance

IT provider with ISO 13485 – is it really crucial?

ISO 13485 certification – how to prepare?

Let’s work on
your challenges together!

Contact with us:

T: +48 609 995 887
E: purbanski@graylight-imaging.com