Services of Zentis Medical
From initial ideation to market launch and beyond, Zentis Medical is your trusted partner every step of the way. We collaborate closely with our clients to develop and maintain software solutions that not only meet regulatory requirements but also exceed industry standards for excellence.
Our approach to Product Lifecycle Services offers three key phases: product development, certification and support.
Product development
Zentis Medical delivers concept validation, prioritizing technology validation spanning UX/UI, architectural design, and software/hardware (PCB/PCBA). Our Feasibility service creates dynamic prototypes for demonstrations. With implementation & verification, we transform prototypes into industrial-grade products, meeting ISO 60601 and IEC 62304 standards, backed by testing and QMS (MDR) compliant documentation.
Certification & Launch
At Zentis Medical, our certification support is comprehensive and tailored to ensure smooth navigation through the certification process. We offer the delivery of the product Technical File, providing crucial documentation for compliance. Throughout the certification cycle, our team provides Q&A support, addressing any queries or concerns that may arise. Additionally, we prioritize rapid issue resolution for new releases, particularly during the Notified Body supervision period, ensuring minimal disruptions. Our commitment extends to providing launch support, including 'Intensive Care' monitoring and support during the critical product launch phase. With a focus on responsiveness, we guarantee rapid response times and prioritize issue resolution to maintain the integrity of your certification journey.
Support & Maintenance
At Zentis Medical, we offer a streamlined support & maintenance process, tailored to each client. We start with an intake phase, reviewing codebase and documentation and setting up access. Then, during transition, we ensure a smooth handover and three months of intense monitoring. In the steady state, we provide ongoing maintenance, performance reporting, and compliant documentation. Clients also have the option to combine support with minor enhancements.
Years of experience
We are familiar with all medical standards and quality processes.
Medical projects
Ranging from low-level firmware development to comprehensive information systems.
Employees
Our employees are highly skilled software professionals and project managers.
Would you like to discuss the possibilities?
Feel free to contact us!
- Zentis Medical
- Boulevard Heuvelink 106
- 6828 KT Arnhem