Product Development
Zentis Medical supports medical device development from concept to implementation. We design and develop for medical devices in regulated environments.
- System architecture and prototyping
- Electronics engineering
- Embedded software development
- Application software development
- Verification, validation and documentation
How we work
Concept & architecture
Architecture design and prototyping to validate technical and regulatory assumptions early.
Engineering, development and implementation
Implementation with structured testing and QMS-aligned documentation.
Verification
Test strategies and traceability aligned with IEC 62304 safety class requirements.
FAQ
What is medical device software development?
Structured development per IEC 62304: requirements, architecture, implementation, verification and risk management, all traceable.
When is IEC 62304 required?
Whenever software is part of a medical device or is itself a medical device (SaMD). Referenced by both EU MDR and FDA.
Certification & Compliance
Zentis Medical works hand in hand with clients to navigate MDR, FDA and related regulatory requirements, partnering closely from architecture review through audit preparation and support to build compliance into every step.
- Technical file preparation
- Architecture and documentation reviews
- Cybersecurity guidance (MDCG 2019-16)
- Notified body question support
- Keeping software documentation compliant after launch
How we work
Gap assessment
We assess your current process against MDR and IEC 62304 requirements and identify gaps.
Documentation
Technical files, risk management files and software documentation are developed collaboratively with the client throughout the product development process, ensuring alignment with applicable standards from the start.
Audit support
We support notified body questions and help ensure your device remains compliant.
FAQ
What is required for MDR compliance?
Technical file, clinical evaluation, post-market surveillance plan, ISO 13485 QMS and notified body for class IIb/III.
How long does certification take?
The timeline to CE marking for Class IIb products depends on factors such as product complexity, regulatory strategy, documentation readiness and notified body timelines. With the right preparation and alignment, the process can be accelerated.
Support & Lifecycle
After market entry, Zentis Medical supports medical devices through sustaining engineering and lifecycle management, keeping your device compliant, secure and operational.
- Codebase and documentation intake
- Updates, releases and issue resolution
- Regulatory alignment as requirements evolve
- Documentation maintenance
- SBOM Monitoring
How we work
Intake
Codebase, documentation and system review to understand the current state.
Transition
Smooth handover with close monitoring and knowledge transfer.
Steady state
Ongoing support, updates, issue resolution and documentation maintenance.
FAQ
What is sustaining engineering?
Maintenance, updates, defect resolution and compliance work on a device already on the market.
How do you maintain compliance after launch?
We track regulatory changes, assess impact, implement updates and keep documentation current.
Consultancy & Architecture
With over 20 years of experience in medical device development, Zentis Medical helps you make informed decisions about your product, technology and development processes. We review and assess existing products, architectures and processes, identify gaps and risks, and provide clear, actionable recommendations based on our hands-on experience. Working closely with your team, we help you determine the right next steps, from addressing technical challenges to meeting evolving regulatory requirements.
- System and solution architecture design
- Technology and platform selection
- Regulatory impact assessments (e.g. Cyber Resilience Act)
- Development process and QMS advisory
- Second opinion / technical due diligence
How we work
Discovery
We map your current architecture, process and regulatory obligations to find the real constraints.
Advisory
Concrete recommendations on architecture, technology choices and process, with regulatory impact made explicit.
Support
We stay involved through implementation to make sure recommendations hold up in practice.
FAQ
Is this only for new products, or also existing ones?
Both. We advise on greenfield architecture as well as on adapting existing products to new requirements such as the Cyber Resilience Act.
How does this differ from your development services?
This is advisory and architecture-level work rather than hands-on implementation, though we're happy to do both.