01 / 03· Engineering-first mindset Our consultants have written production code for FDA-cleared and CE-marked devices. Advice grounded in real delivery, not just frameworks.
02 / 03· Regulatory + technical fluency We bridge the gap between your development team and regulatory requirements, so compliance does not become a bottleneck.
03 / 03· Budapest & Singapore With offices in Europe and Asia, we support international market entry and time-zone coverage for global teams.
Co-founder & CTO Péter Török, MBA Delivery management, unblocking stalled projects, and helping teams hit deadlines with the right team composition. 20+ years in MedTech. Former Director of Software Development at Siemens Healthcare (syngo.via), Erlangen. Led teams at evosoft, evopro and Mediso R&D. Discovery callMore about Péter
Co-founder & Managing Director Dr. Linda Szántó Business development, university partnerships, and advisory for EU-funded projects. Lawyer by training. Female Business Leader of the Year 2025. Consultant at the ELTE Faculty of Informatics. Discovery callMore about Linda
Singapore office lead András Török, MBA Strategy, financial planning, and market-entry support for companies targeting Asian markets. MBA from INSEAD. 15+ years in financial services across Singapore and Switzerland. Former roles at Standard Chartered and UBS. Discovery callMore about András
Head of Software Development Tamás Fodor Technical process reviews, quality and compliance for highly regulated devices, test automation, and efficiency improvements. 10+ years in healthcare software. Dual degrees in software and medical engineering (BME, Semmelweis). Expert in DICOM, HL7, PACS and DevOps. Discovery callMore about Tamás
01 Regulatory strategy & compliance FDA 21 CFR Part 820 and EU MDR 2017/745 guidance Risk management (ISO 14971), usability (IEC 62366) Cybersecurity (IEC 62443), HIPAA and GDPR compliance Regulatory documentation and submission packages
02 SDLC optimization QMS and development process integration Automated testing pipelines (CI/CD) with traceability IEC 62304 compliant development workflows Quality assurance standards and documentation
03 Product & technology strategy Software architecture evaluation for scalability Cloud-native infrastructure for SaMD and imaging Legacy modernization and API standardization AI/ML implementation for diagnostics and CDSS
04 Market & commercial strategy International market entry (Europe and Southeast Asia) Go-to-market plans and product launch strategy Post-launch scaling with clinical insights Strategic planning for new software products
05 Team & organizational development Agile coaching for self-organizing teams Leadership development and shadow coaching Cross-functional collaboration frameworks Mentoring for technical and product leads
06 Specialized advisory Medical device interoperability (DICOM/PACS, HL7/FHIR) Clinical workflow optimization HIS / RIS / OIS integration Risk management and cybersecurity guidance
01 Discovery call We learn about your product, regulatory context and challenges. Free, no commitment.