Software as Medical Device (SaMD) Development

End-to-end SaMD development from concept through regulatory approval to post-market surveillance. We’ve been there as interim CTO/CPO—we know the FDA 510(k) process, EU MDR requirements, and ISO 13485/62304 standards. Strategy, design, development, and regulatory submission—all integrated.

FDA/EMA Regulatory Compliance

Hands-on experience navigating FDA and EMA approval processes. We’ve achieved medical device certification and understand Quality Management Systems (ISO 13485), risk management (ISO 14971), and clinical evaluation requirements. Not just advisors—we’ve done the submissions.

Digital Therapeutics (DTx) & Remote Patient Monitoring

Evidence-based digital therapeutics platforms and RPM solutions. We understand clinical validation requirements, reimbursement pathways, and the unique UX needs of patients and healthcare providers. HIPAA-compliant architecture that scales.

Healthcare Platform Engineering

Secure, scalable platforms for healthcare delivery. HL7/FHIR integration, electronic health record connectivity, and data interoperability. We’ve built systems handling sensitive health data with GDPR/HIPAA compliance and performance optimization (500%+ improvements delivered).

Clinical Data Integration & Analytics

Real-world evidence generation, clinical trial management systems, and healthcare analytics. Privacy-first architecture for patient data, with secure data pipelines and analytics that drive clinical decisions.

Why Choose Starsong Consulting for Healthcare

Hanno Alternative: Since Hanno’s wind-down in 2023, the European healthcare tech market has lacked specialized SaMD expertise combining regulatory knowledge with hands-on development. We fill that gap with former CTO/CPO experience, actual medical device certifications, and proven delivery track record.

Former Medical Device CTO: Not consultants who studied healthcare—we’ve been interim CTO/CPO for medical device companies. We’ve led teams through certification, presented to regulators, and shipped compliant products.

EU/DACH Expertise: Berlin-based with deep understanding of European regulatory landscape (MDR, GDPR, national requirements). Native German/English capabilities for seamless regulatory communication.