Designing software and electronics for medical devices, from system architecture to implementation. We combine embedded and application software development with electronics design, focused on safety, usability and compliance.
Software and consultancy partner for MDR/FDA-compliant medical devices
→ More about usProviding regulatory, cybersecurity and compliance consultancy for medical devices. From architecture reviews and technical files to audit support, we help you meet MDR and FDA requirements with confidence.
Supporting medical devices throughout their lifecycle with sustaining engineering and consultancy. We manage updates, compliance changes and post-market needs to keep your device secure and future-ready.
Software and consultancy partner for MDR/FDA-compliant medical devices.
20
Years of experience
We are familiar with all medical and relevant standards and quality processes and know the pitfalls in medical device development.
30
Medical projects
From electronic design, low level firmware and embedded software to full application platforms and connected systems.
12
Employees
Highly skilled engineers, consultants and project managers dedicated to medical technology.
At Zentis Medical, we specialize in software and electronics design for medical devices, combining development and consultancy across the full product lifecycle. From concept validation and architecture to implementation, compliance and long-term support, our expertise helps ensure safe, compliant and future-ready medical technology.
Working with Zentis
Working with us means you have passionate and committed people at your side who are driven by results and like to co-operate with other teams. We can help with an entire project or just a specific part, so we can make a big difference in a short time. We are also dynamic and can easily take part in any active project and give substantive advice right on the spot, even when you are working with innovative new techniques.
Get to know us better →Highlighted project: Ivy Duo+ infusion pump
Zentis Medical contributed to the software architecture, development and verification of the Ivy Duo+ infusion pump, in compliance with IEC 62304 and IEC 60601. In close collaboration with Ivy Medical, we supported both the technical implementation and the architectural decisions required for a safe and reliable real-time system.
The device is an ARM-based, battery-powered class IIb medical device featuring an innovative pumping mechanism focused on patient mobility, safety and workflow efficiency. Special attention was given to real-time performance, alarm handling and robustness within a dynamic and innovative development environment.
Read more about our projects →Vacancy Embedded Software Engineer
Zentis is looking for a new colleague who is interested in developing embedded software solutions for high-tech systems.
View this job →
“Zentis is the perfect partner for the software development of our innovative infusion pump. The team works efficiently and thinks along about the functionality of the whole product. Their work is of high quality, and we experience the cooperation as very pleasant.”
“Zentis proved to be a valuable partner in both the technical aspects as well as the regulatory aspect when developing a medical device.”
“Zentis supported the software development of Kaleido and was responsible for aspects such as architecture and testing, working in line with IEC 62304 and IEC 60601.”
“The Zentis team understands their metier from beginning to end: from a high-level architecture to the unit test framework throughout the code …”
Would you like to discuss the possibilities?
Feel free to contact us!
- Zentis Medical
- Boulevard Heuvelink 106
- 6828 KT Arnhem
Questions? Please do ask! Contact us at info@zentis.nl