What we do
End-to-end support for medical device development
Certified quality
ISO 13485 certified
Our quality management system is certified to ISO 13485 by BSI. ISO 13485 is the international quality management standard for medical device design and development, and the quality system basis that both EU MDR and the FDA build on. For you, it means our development work is planned, documented and verified in a way that fits directly into your technical file.
- Certificate number
- MD 738731 (BSI, valid until 8 July 2027)
- Scope
- Design and development for third parties of software components for use in medical devices and prototypes, including provision of related services: secondment and consultancy.
Featured project
Ivy Medical
Ivy Duo+ infusion pump
Zentis developed the software of the Ivy Duo+, an ARM-based class IIb device enabling patients to receive infusion therapy safely while maintaining mobility.
IEC 62304IEC 60601ARMClass IIb
View project →Client reviews
What our clients say
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.
M
Melcher Frankema
Founder, Ivy Medical
Zentis proved to be a valuable partner in both the technical and regulatory aspects when developing a medical device.
H
Hasse Muller
CEO, PSW Medical (Parkinson Smartwatch)
The Zentis team understands their metier from beginning to end: from a high-level architecture to the unit test framework.
H
Hans Meijs
Founder & partner, NICE Medical
Insights
Ideas and expertise from our engineers
Ready to discuss your medical device project?
We are happy to talk through your challenges, whether you are starting fresh or need support on an existing device.
Feel free to contact us →