Services of Zentis Medical
From early concept to post-market support, Zentis Medical is your partner throughout the full lifecycle of a medical device. We work closely with our clients to design, develop and support software and electronics solutions that meet regulatory requirements and are ready for long-term use in clinical practice.
Our services cover three core phases of the medical device lifecycle: product development, certification and compliance, and sustaining engineering.
Product development
Zentis Medical supports medical device development from concept to implementation. We provide system architecture, embedded and application software development, and electronics design, with a strong focus on safety, usability and compliance.
During early phases, we help validate concepts and technical feasibility through architecture studies and prototyping. In later stages, we support implementation, verification and documentation in line with standards such as IEC 62304 and IEC 60601. Our work is supported by structured testing and QMS-aligned documentation to ensure a reliable and traceable design.
Certification & Compliance
Zentis Medical provides regulatory and compliance support to help you navigate MDR, FDA and related standards. Our services include architecture and documentation reviews, technical file preparation, cybersecurity guidance and hands-on support during audits and assessments.
Throughout the certification process, we assist with questions from notified bodies, support issue resolution for new releases and help ensure your device remains compliant as requirements evolve. Our involvement can range from advisory support to implementing the necessary changes in software or electronics design.
Support & Lifecycle
After market entry, Zentis Medical supports medical devices through sustaining engineering and lifecycle management. Our support is tailored to each client and typically starts with an intake phase, including review of the codebase, documentation and system setup.
During the transition phase, we ensure a smooth handover and close monitoring. In steady state, we provide ongoing support, updates, issue resolution, documentation maintenance and regulatory alignment. Support services can be combined with minor improvements or redesign activities when needed.
Years of experience
We are familiar with all medical and relevant standards and quality processes and know the pitfalls in medical device development.
Medical projects
From electronic design, low level firmware and embedded software to full application platforms and connected systems.
Employees
Highly skilled engineers, consultants and project managers dedicated to medical technology.
Would you like to discuss the possibilities?
Feel free to contact us!
- Zentis Medical
- Boulevard Heuvelink 106
- 6828 KT Arnhem