Medical Device Software Development

Medical Device Software Specialists

Expert developers and consultants specializing in medical imaging, radiotherapy, and Software as a Medical Device (SaMD). We build treatment management systems, medical imaging platforms, and hospital integration solutions. Our developers work within ISO 13485 and IEC 62304 environments, delivering technical excellence on certified medical device projects.

Deep expertise in medical imaging platforms, hospital and clinical system integration, clinical decision support, treatment planning systems, AI/ML diagnostics, digital health platforms, and cloud-native SaMD.

Software as a Medical Device

ISO 13485 & IEC 62304

FDA & EU MDR Compliance

We Know These Standards Inside Out

Leadership team with 20+ years in regulated medical device software development. Proven experience delivering large-scale, market-ready systems under FDA, EU MDR, and ISO standards for global MedTech companies.

ISO 13485

Quality Management

Working within clients’ certified QMS environments

IEC 62304

Software Lifecycle

Complete SDLC implementation daily on every project

ISO 14971

Risk Management

FMEA, hazard analysis, risk control throughout lifecycle

IEC 62366

Usability

Use-related hazard identification and UI validation

FDA & EU MDR

Regulatory

21 CFR Part 820 and MDR 2017/745 compliance

DICOM/HL7/FHIR

Interoperability

Medical imaging and healthcare data exchange

GDPR & HIPAA

Data Protection

Privacy-by-design for patient data handling

IEC 62443

Cybersecurity

Security-by-design for connected devices

How we work: We typically integrate into client quality management systems, following their processes and standards. Our extensive work on certified medical device projects demonstrates our ability to deliver on the most demanding regulatory requirements.

Why Medical Device Companies Choose Silurus

We’re medical device software specialists who understand the complexity of certified development. Deep technical expertise in radiotherapy, medical imaging, and healthcare integration—combined with proven experience on the most demanding regulatory projects.

Medical Device DNA

Radiotherapy, medical imaging, treatment planning—this is what our 40+ developers do every day.

Proven at Scale

8+ years with market leaders on mission-critical systems. When companies need medical software expertise, they call us.

Regulatory Experience

Extensive work on ISO 13485 and IEC 62304-certified projects. We understand what regulatory compliance really means.

Global Reach

Budapest + Singapore offices supporting European and Asian markets with 24/7 coverage.

Specialized Medical Software Services

Comprehensive solutions from MVPs to enterprise-scale medical device systems

Medical Imaging & Radiotherapy

Advanced imaging platforms and treatment planning systems.

C++

C#

PYTHON

DICOM

ITK/VTK

Healthcare System Integration

Seamless connectivity with hospital and clinical information systems

HL7/FHIR

C#

JAVA

REST API

SQL

Cloud-Native Medical Platforms

Scalable cloud infrastructure for SaMD and medical imaging

AZURE

DOCKER

KUBERNETES

.NET

NODE.JS

Regulatory Compliance & QA

IEC 62304-compliant development and quality assurance

AZURE DEVOPS

JIRA

GIT

SELENIUM

Software as a Medical Device (SaMD)

End-to-end development of standalone medical software applications

PYTHON

TENSORFLOW

REACT

FLUTTER

Legacy System Modernization

Upgrade and migrate aging medical device software

C++ TO C#

CLOUD MIGRATION

API MODERNIZATION

AI Diagnostic Tool Development

Advanced AI/ML systems for medical diagnostics and decision support

PYTHON

PYTORCH

OPENCV

TRANSFORMERS

MVP & Proof of Concept

Rapid prototyping for startups and innovation teams

AGILE

RAPID PROTOTYPING

FLEXIBLE STACK

Is Your Medical Device Software Regulatory-Ready?

Take our free 5-minute assessment to evaluate your compliance with IEC 62304, ISO 13485, and ISO 14971 standards. Get a personalized gap analysis and actionable recommendations.

Who We Serve

Specialized medical device software expertise for companies at every stage

Market Segment

Company Types

What You Get

Medical Device Manufacturers

Radiotherapy equipment makers
Medical imaging companies
Treatment planning vendors
Oncology technology firms

Developers experienced in your domain
Deep DICOM, HL7 protocol expertise
Long-term partnership approach (2-7+ years)
Work within your ISO 13485/IEC 62304 processes

Healthcare Technology Companies

Medical software vendors
Healthcare IT companies
Digital health platforms
SaMD developers

Senior developers who understand healthcare
Regulatory documentation expertise
Seamless integration into your team
Azure cloud infrastructure experience

Research & Development Teams

University research centers
Medical research institutions
MedTech innovation labs
Clinical trial centers

Algorithm hosting platform development
Medical imaging processing expertise
Scalable cloud infrastructure (Azure)
Academic collaboration experience

Not sure if we’re the right fit for your project? Let’s discuss your specific needs.

Flexible Engagement Models

Choose how you’d like to work with our medical device software specialists

Integrated Developers

Senior medical device specialists who join your team and work within your development processes and quality systems.

Regulatory-experienced specialists, not generalists
Deep DICOM, HL7, medical imaging knowledge
Work within your processes and tools
Quick integration (2 weeks ramp-up)
Flexible duration, prefer long-term partnerships

Best for: Scaling your team with medical device experts who understand ISO 13485 and IEC 62304 environments

Dedicated Team

A complete team of medical device specialists working exclusively on your project with full-time commitment.

Team lead + senior developers + QA specialists
Full-time dedicated to your project
Deep knowledge of regulatory requirements
Scalable team size as project evolves
Ideal for long-term partnerships (6+ months)

Best for: Complex, multi-year medical device projects requiring dedicated resources and deep technical expertise

Full-Cycle Development

End-to-end project delivery from requirements through deployment and regulatory documentation.

Complete development and project management
Requirements analysis through deployment
IEC 62304-compliant development lifecycle
Documentation for regulatory submissions
Post-launch support and maintenance

Best for: MedTech startups and companies needing turnkey development with regulatory expertise

Not sure which model fits your project?

We’re flexible and can adapt to your needs. Most of our partnerships are long-term (2+ years), but we’re open to shorter engagements and can combine models as your project evolves. Let’s discuss your specific requirements.

How We Support Your Medical Device Software Development

Our developers integrate seamlessly into your ISO 13485/IEC 62304-certified processes at every stage

01 Planning and Requirements

Work with your team to define technical requirements and system architecture

Support feasibility analysis and technology stack selection

Contribute expertise in DICOM, HL7, and medical imaging standards

Integrate into your project planning and risk assessment processes

Follow your quality management system from day one

02 Architecture and Design

Design scalable system architecture for medical imaging and radiotherapy applications

Create detailed technical specifications aligned with IEC 62304 requirements

Plan data flows and integration points with HIS/RIS/OIS systems

Design cloud infrastructure (Azure) for medical device software

Develop security architecture compliant with HIPAA and GDPR

03 Software Development

Develop backend and frontend components using C++, C#, Python, Java

Implement DICOM parsers, HL7 interfaces, and medical data handling

Build treatment planning algorithms and medical imaging processing

Follow your coding standards and configuration management procedures

Maintain comprehensive documentation per IEC 62304 requirements

Use your version control and CI/CD pipelines

04 Integration and Interoperability

Integrate with PACS, RIS, HIS, and oncology information systems

Implement DICOM communication and HL7/FHIR data exchange

Connect to treatment machines and medical imaging equipment

Develop RESTful APIs and microservices for healthcare platforms

Ensure seamless data flow across your medical device ecosystem

05 Testing and Quality Assurance

Execute comprehensive testing following your V&V plan

Perform unit, integration, system, and regression testing

Conduct risk-based testing per ISO 14971 requirements

Automated testing using your CI/CD framework

Document test results and traceability matrices

Support usability testing and clinical validation activities

06 Regulatory Documentation

Create technical documentation aligned with IEC 62304 and ISO 13485

Support preparation of regulatory submission packages (FDA, EU MDR)

Document software architecture, design specifications, and test protocols

Maintain traceability from requirements through validation

Contribute to risk management files and clinical evaluation reports

07 Deployment and Launch Support

Support production deployment and go-live activities

Configure cloud infrastructure and monitoring systems

Assist with installation and commissioning at customer sites

Provide knowledge transfer and training documentation

Establish post-market surveillance procedures

08 Maintenance and Support

Ongoing software maintenance and bug fixes

Security patches and performance optimization

New feature development and system enhancements

Support complaint management and root cause analysis

Update documentation for software changes and regulatory updates

Need experienced developers at any stage?

Whether you’re starting a new project or need reinforcement on an existing one, we’re ready to help.

Frequently Asked Questions

Everything you need to know about working with Silurus

Do you have ISO 13485 certification?

We don’t maintain our own ISO 13485 certification. We typically work within client environments, following their quality management systems and development processes.

Our developers have extensive experience on ISO 13485 and IEC 62304-certified projects—including 3+ years with Siemens Healthineers on their medical imaging and radiotherapy systems. We understand regulatory requirements and work effectively in certified development environments.

How long does a typical medical device software project take?

Project timelines vary based on complexity and regulatory requirements:

Simple integrations: 3-6 months
Medical imaging platforms: 12-36 months
Full treatment planning systems: 24-48+ months

Most of our partnerships are long-term (2-7+ years), as we continue with maintenance, updates, and new feature development after initial release.

What regulatory standards do your developers understand?

Our developers have extensive experience with:

IEC 62304: Medical device software lifecycle processes
ISO 13485: Quality management systems for medical devices
ISO 14971: Risk management for medical devices
IEC 62366: Usability engineering for medical devices
FDA 21 CFR Part 820: Quality system regulations
EU MDR 2017/745: Medical device regulation
DICOM, HL7/FHIR: Healthcare interoperability standards
HIPAA, GDPR: Data protection compliance

This knowledge comes from years working on certified medical device projects, not just reading documentation.

What is your team structure and who will work on my project?

We have 40+ medical device software specialists. A typical project team includes:

Project/Team Lead: Coordinates development and client communication
Senior Developers: Experts in C++, Python, DICOM, HL7, medical imaging
QA Specialists: Testing and validation with regulatory focus
Technical Architects: For complex system design (as needed)

You get specialists who understand medical device software, not general software developers.

What are your pricing models and rates?

We offer flexible engagement models starting from 25 EUR/hour:

Integrated Developers: Hourly or monthly rates for adding specialists to your team
Dedicated Team: Monthly rate for a full-time team (lead + developers + QA)
Fixed-Price Projects: For well-defined scope (less common in medical devices)

Most clients prefer Integrated Developers or Dedicated Team models for the flexibility they provide. Contact us for a detailed proposal based on your specific needs.

Do you provide post-launch support and maintenance?

Yes, we provide comprehensive post-launch support:

Maintenance and Updates: Bug fixes, performance optimization, new features
Regulatory Updates: Changes required for evolving standards
Technical Support: Issue resolution and troubleshooting
Documentation Updates: Keeping technical files current

Most of our client relationships are long-term—we’re still working with companies we started with years ago.

What healthcare systems can you integrate with?

We have deep expertise in healthcare system integration:

DICOM/PACS: Medical imaging systems and picture archiving
HL7/FHIR: Healthcare information exchange protocols
HIS/RIS/OIS: Hospital, radiology, oncology information systems
Treatment Machines: Radiotherapy equipment interfaces
EMR/EHR: Electronic medical records systems
Cloud Platforms: Azure-based infrastructure (certified partner)

Our 48-month ongoing project with a global medical imaging leader focuses specifically on these integration challenges.

How do you handle intellectual property and confidentiality?

We take IP protection seriously:

Your IP: All code and documentation developed belongs to you
NDAs: Standard practice before any project discussion
Data Security: GDPR and HIPAA-compliant data handling
Secure Infrastructure: Access controls, encrypted communication

We understand the critical nature of confidentiality in this industry.

Let’s discuss how our expertise can support your project