Medical device

We can do the project together

 

Do you want to develop
Software as a Medical Device?

Check our approach to developing medical software that matches regulations and clinical workflow.

medical device

What we offer

  • Development of a project compliant with your idea but also with technological and medical regulations as well as best practices. Our multidisciplinary team consisting of engineers, bioengineers, scientists and clinicians ensures that the goals of your project will be met.
  • During software development process (Software as a Medical Device) we create certification documentation. By developing a project with us, you will receive professional documentation that will support and speed up the certification process of your solution. We are able to develop Software as a Medical Device tailored to the client’s needs.
  • Assistance within the whole software development lifecycle, whether your in pre-project, feasibility, proof of concept or development phase. We can also help you with maintenance when the project is done and your product ready.

Why us

  • Experience. We were involved in the development of certified medical devices which successfully are implemented in clinical workflow and are used in practice.
  • We work according to our own Quality Management System. Every process we have implemented internally and our work approach are quality-based.
  • We have implemented ISO/IEC 27001 because we know data security’s importance in the medical device industry.
  • Our internal QMS meets the ISO 13485 standard, as confirmed by the Certificate for the Management System according to ISO 13485:2016.
  • Our knowledge of the ISO 14971 standard and the ability to create healthcare software systems while complying with the IEC 62304 standard will ensure the relevant certification you may require.
  • We have experience in software development compliant with CE and FDA.

Learn more about our competences

elder lady is talking with a younger woman . There is a park behind them.

Post-Operative Delirium and Post-Operative Cognitive Dysfunction prediction model.

gralight imaging iso 13485 medical compliance

Lessons Learnt: Certified medical product development.

man and woman discuss reports

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