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.
Medical device software development – our 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 is met.
- During the software development process we create documentation that supports and speeds 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 is ready.
Experienced team in building up medical device software
- Experience. We were involved in the development of certified medical devices that have 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 the development of medical software that meet the requirements of this standard. Our competences support client’s certification process.
Proven experience in creating AI solutions for medical device
Post-Operative Delirium and Post-Operative Cognitive Dysfunction prediction model.
Lessons Learnt: Certified medical product development.
Bleepa™ – a secure instant messaging system
