Custom medical device software development
Custom medical device software that meets the strictest requirements. From Software as a Medical Device (SaMD) to embedded device software. IEC 62304 compliant, MDR-conformant and built for CE marking. From concept and classification through to validation and market approval.
Why custom medical device software?
Medical software must not only be functional, but also demonstrably safe, reliable and compliant with the European Medical Device Regulation (MDR). Standard software frameworks do not take into account the specific requirements of IEC 62304, risk management under ISO 14971 and the traceability needed for CE marking.
Built for compliance from day one
With custom medical device software, compliance is not added afterwards; it is part of the architecture and the development process. Every requirement is traceable, every change is documented and every release goes through verification and validation in line with IEC 62304.
At Appfront, we build custom software that is entirely yours. You are the manufacturer; we are your development partner. Together, we guide you through the journey from classification to market approval.
Our expertise
We develop a wide range of medical software, from standalone SaMD applications to embedded firmware for medical equipment. Every solution is built in line with the applicable standards and regulations.
SaMD & standalone applications
Software as a Medical Device (SaMD) that fulfils a medical purpose on its own: diagnostics, monitoring, treatment support or risk assessment. From classification under MDR Rule 11 through to CE marking and EUDAMED registration.
- MDR Rule 11 classification
- IEC 62304 software lifecycle
- Clinical evaluation and evidence building
- EUDAMED registration
Embedded device software
Firmware and control software for medical equipment: point-of-care devices, laboratory equipment and therapeutic systems. Developed in line with IEC 62304, with full traceability from requirements to test results.
- Firmware for medical hardware
- Real-time control software
- Hardware-software integration
- IEC 62304 safety classes A, B and C
Diagnostics & monitoring
Software for processing, analysing and presenting diagnostic data. From medical image processing and laboratory results to continuous patient monitoring with real-time alerts for abnormal values.
- Medical image processing (DICOM)
- Continuous patient monitoring
- Laboratory result processing
- Alarm systems and escalation
Clinical decision support
Clinical Decision Support Systems (CDSS) that support healthcare professionals with diagnosis, treatment choices or medication checks. Based on rules, guidelines or AI models, with full traceability of the underlying rationale.
- Rule-based and AI-driven CDSS
- Guideline implementation
- Drug interaction checking
- Transparent decision logic (explainability)
Patient apps & wearables
Mobile applications and wearable software for telemonitoring, treatment adherence and patient-reported outcomes. Designed for patients with attention to usability (IEC 62366) and privacy (GDPR, NEN 7510).
- Telemonitoring and remote care
- Wearable data integration
- IEC 62366 usability engineering
- MedMij/PGO compatibility
Interoperability and integrations
Integrations with healthcare information systems, EHRs and other medical systems via standardised protocols. From HL7 FHIR and DICOM to integrations with the Landelijk Schakelpunt (LSP, the national switch point) and MedMij networks.
- HL7 FHIR and HL7v2 integration
- DICOM for medical images
- EHR integrations
- LSP and MedMij/PGO
Each area of expertise can be deployed as part of a larger platform or as a standalone web application. We would be happy to advise you on the right approach and classification.
Regulatory compliance & standards
Medical software must meet a coherent body of European regulation and harmonised standards. We build software designed from the outset to meet these requirements, so the route to CE marking runs smoothly.
Standards and norms
We develop in line with the harmonised standards required for CE marking under the MDR. This covers full software lifecycle management, risk management and usability engineering.
- IEC 62304 — Software lifecycle processes and safety classes (A, B, C)
- ISO 14971 — Risk management for medical devices
- ISO 13485 — Quality management system
- IEC 62366 — Usability engineering
- IEC 81001-5-1 — Cybersecurity for medical software
MDR & CE marking process
The CE marking process begins with classification under MDR Rule 11 and runs through technical documentation, clinical evaluation and conformity assessment to registration in EUDAMED. We support you at every step.
- Classification — Determining the risk class (I, IIa, IIb, III)
- Technical documentation — Design history file, V&V reports
- Clinical evaluation — Literature review or clinical investigation
- Post-market surveillance — Vigilance and PMCF
- AI Act — Additional requirements for AI-driven medical software
The regulatory landscape is complex. Our IT consultants help you with a gap analysis and a roadmap to compliance.
Technologies we use
Medical software requires a technology stack that is not only performant but also auditable, reproducible and suitable for validated environments. We choose technologies proven in regulated sectors.
Backend & data
Python and Node.js for application logic, PostgreSQL for structured medical data, and message queues for asynchronous processing. Every component is versioned and reproducible for audit purposes.
- Python, Node.js and C/C++ (embedded)
- PostgreSQL with audit logging
- HL7 FHIR server implementation
- Fully versioned and reproducible
Frontend & mobile
React and TypeScript for web interfaces, React Native for mobile apps. Designed according to IEC 62366 usability principles, with attention to accessibility and error prevention in clinical environments.
- React and TypeScript
- React Native (iOS and Android)
- WCAG accessibility
- Usability testing in line with IEC 62366
Cloud & DevOps
Validated cloud environments on AWS or Azure with full audit trails. CI/CD pipelines that make every build traceable. Infrastructure as Code for reproducible deployments.
- AWS and Azure (validated environments)
- Docker with validated images
- CI/CD with full traceability
- Infrastructure as Code (Terraform)
Test your idea first: a working prototype in 1 day
With OneDayBuild, we turn your idea into something tangible in one day for €1,150, so you can see whether further development is worth the investment. Decide to go ahead with the full build? Then we credit the full cost.
Explore OneDayBuild →Integrations with healthcare systems
Medical software must communicate seamlessly with the existing healthcare IT landscape. We build API integrations in line with standardised healthcare protocols for safe and reliable data exchange.
HL7 FHIR & DICOM
Integration with healthcare information systems via HL7 FHIR (R4), HL7v2 and DICOM. From patient data and medication to medical images and laboratory results. In line with the Dutch implementation guides.
EHR, LSP and MedMij
Integrations with electronic health records (EHRs), the Landelijk Schakelpunt (LSP, the national switch point) for medication transfer, and MedMij networks for personal health environments (PGO). We also build custom middleware for legacy systems.
Medical IoT & devices
Connect your medical software to sensors, wearables and IoT platforms. From Bluetooth connections with measuring equipment to real-time data streaming from bedside monitors and home monitoring devices.
Why choose Appfront as your development partner?
Building medical device software requires a partner who understands not only how to build software but also the regulatory landscape. Combining IEC 62304-compliant development, risk management and technical excellence calls for specialist expertise.
Our approach
Every project starts with a classification and gap analysis: what is the intended purpose, which risk class applies, and which standards are relevant? We then build a development plan in line with IEC 62304 and develop in sprints with verification and validation built into each one.
- Classification and gap analysis upfront
- IEC 62304-compliant development process
- Built-in V&V in every sprint
- Design history file and traceability
- Support with clinical evaluation
Take a look at our full range of services for an overview of our expertise.
What you can expect from us
We build medical software that stands up to the strictest audits. Clean, documented code, full traceability, automated testing and an architecture ready for CE marking. After handover, we support post-market surveillance and software updates.
If you place the device on the market yourself, managing your technical documentation and post-market surveillance comes with it. You can read how we build that system under MDR technical file development.
- Ownership of all source code
- Technical documentation for notified bodies
- Post-market software updates and maintenance
- Experience with SaMD and embedded medical software
- Collaboration with your regulatory affairs team
Curious about how we work? See our work for examples.
Security and privacy
Medical software processes special category personal data within the meaning of the GDPR. The requirements for security, privacy and data integrity are therefore higher than for regular software. We build security in as a core part of the architecture.
- IEC 81001-5-1 cybersecurity for medical software
- NEN 7510, NEN 7512 and NEN 7513 compliance
- GDPR and DPIA for special category personal data
- End-to-end encryption (TLS/mTLS, AES-256)
- Role-Based Access Control and audit trails
- Penetration testing and vulnerability assessments
Read more about our information security policy and vulnerability disclosure policy.
Frequently asked questions about medical device software
Ready to develop your medical software?
Discover how we can help you develop medical device software that meets the strictest requirements, from classification and architecture through to CE marking and post-market support. Explore our services, find out more about us, or get in touch directly.