OUR SERVICES
Additional Services:
Consulting and Project Management
Why Silurus for Medical Device Software and for Business Development Consulting?
Our consultants are also experienced business leaders, 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.
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 Consultants
Péter Török, MBA
Péter provides technology and industry consulting, primarily for companies operating in regulated environments, complemented by a strong project management approach. He helps organizations carry out complex development and implementation projects in a transparent and controlled manner, while ensuring continuous alignment between technical solutions and business expectations.
Péter is Co-Founder and CTO of Silurus Software, with more than two decades of industry experience. He previously worked in team lead and project management roles, later as Director of Software Development at Siemens Healthcare (syngo.via) in Erlangen, and held senior positions at evosoft, evopro, and Mediso R&D.
Dr. Linda Szántó
Linda supports companies turning to us with business and strategic consulting, particularly in matters of growth, organizational development, and international market entry. Her experience includes structuring complex decision-making situations, establishing effective cooperation among various stakeholders, and ensuring that business objectives remain aligned with operational and resource realities.
Linda is Co-Founder and Managing Director of Silurus Software, a lawyer by education. She is responsible for sales, marketing, recruitment, HR, international expansion, and digitalization, and has previously gained experience at a law firm, the Hungarian Data Protection Authority, and as an IT project manager. In 2025, she was awarded the title “Female Business Leader of the Year.”
András Török, MBA
András supports companies with technology and operational consulting, particularly in the thoughtful design and optimization of systems, processes, and solutions. His goal is to ensure that clients’ technical decisions are sustainable, scalable, and well-founded from a business perspective.
András leads the Singapore office of Silurus Software and brings more than 15 years of international experience in financial services in Singapore and Switzerland, including roles at Standard Chartered and UBS. He holds an MBA from INSEAD and strengthens the consulting services with strong international and business expertise.
Tamás Fodor
Tamás focuses his consulting work on structured execution and project management. He supports clients in project planning, scheduling, and execution, paying particular attention to risk management, efficient use of resources, and continuous, transparent communication among stakeholders.
Tamás is Head of Software Development at Silurus Software. He has over ten years of experience in healthcare software development, holds a software engineering degree from Budapest University of Technology and Economics and a medical engineering degree from Semmelweis University, and has hands-on experience with IEC 62304-compliant development, medical imaging, radiotherapy, DICOM, HL7, PACS, DevOps, as well as engineering leadership and business development.
Our Expertise in Medical Device Software Consulting
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 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 Advisory
Guidance on medical device interoperability: DICOM/PACS, HL7/FHIR, HIS/RIS/OIS
Clinical workflow optimization and integration consulting with hospitals and research centers
Guidance on risk management, usability, and cybersecurity in the medical device context
