Medical device
Do you want to develop
Software as a Medical Device?
We can do the project together.
Check our approach to developing medical software that matches regulations and clinical workflow.
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 we create documentation that will support and speed up the certification process of your solution. Thanks to our experience, by developing a project with us, you will receive professional documentation. 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 experience in software development compliant with CE and FDA.
- 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.
- Our internal QMS meets the ISO 13485 standard. We are experienced practitioners in development of medical software that meet the requirements of this standard. Our competences support client’s certification process.
Learn more about our competences
Post-Operative Delirium and Post-Operative Cognitive Dysfunction prediction model.
Lessons Learnt: Certified medical product development.
Bleepa™ – a secure instant messaging system
