Consulting and Project Management for Medical Device Software

At Silurus Software, we provide specialized consulting and project management services for companies developing medical device software. Our team leverages decades of experience in ISO 13485 and IEC 62304 compliant software development, FDA and EU MDR regulatory environments, and complex healthcare system integration to deliver practical, high-impact guidance.

Our Expertise in Medical Device Software Consulting Includes:

1. Regulatory Strategy and Compliance

• Advising on FDA 21 CFR Part 820 and EU MDR 2017/745 compliance for new and existing medical software products

• Guidance on risk management (ISO 14971), usability engineering (IEC 62366), and cybersecurity standards (IEC 62443)

• Developing and reviewing regulatory documentation, submission packages, and post-market surveillance procedures

• Ensuring privacy-by-design and HIPAA/GDPR compliance for patient data and connected devices

2. Product and Technology Strategy

• Evaluating software architecture and technology stack for scalability, maintainability, and regulatory compliance

• Advising on cloud-native infrastructure and secure platform design for SaMD and medical imaging systems

• Support in legacy system modernization, migration strategies, and API standardization

• Guidance on AI/ML implementation for diagnostics, clinical decision support, and treatment planning tools

3. Software Development Lifecycle (SDLC) Optimization

• Integration into client QMS and development processes

• Implementing automated testing pipelines (CI/CD) and ensuring full traceability from requirements to validation

• Establishing best practices for unit, integration, system, and regression testing

• Developing internal standards for team productivity, documentation, and quality assurance

4. Market and Commercial Strategy

• Advising on international market entry, particularly in regulated regions such as Europe, the U.S., and Southeast Asia

• Supporting product launch strategies, go-to-market plans, and post-launch scaling

• Integrating clinical, regulatory, and market insights into strategic planning for new software products

5. Team and Organizational Development

• Agile coaching for self-organizing teams in medical software projects

• Leadership development and shadow coaching for technical and product leads

• Mentoring for effective cross-functional collaboration, from engineering to clinical and regulatory teams

6. Specialized Workshops and Advisory

• Guidance on medical device interoperability: DICOM/PACS, HL7/FHIR, HIS/RIS/OIS

• Clinical workflow optimization and integration consulting with hospitals and research centers

• Hands-on workshops for risk management, usability, and cybersecurity in the medical device context

Why Silurus for Medical Device Software Consulting?

Our consultants are also experienced developers and technical leads who have delivered large-scale medical software systems in FDA and MDR-regulated environments. This combination of practical software expertise and regulatory knowledge ensures that our advice is actionable, compliant, and aligned with real-world development practices.

By working with Silurus, companies gain a partner capable of guiding every stage of medical device software development, from early concept and regulatory strategy to full deployment, integration, and post-market support.