Shasta Medical s.r.o.
Clinical development and market-entry partner for health innovators.
About Shasta Medical
Shasta Medical supports biopharma, medtech, and AI-driven health companies on their journey from concept to commercialisation. We design and run high-quality studies, prepare regulatory documentation, and connect innovators with the right commercial channels across Europe. With integrated teams in Singapore, the United States, and the EU, we deliver programmes seamlessly across continents.
End-to-end clinical development (IMPs): Strategy and execution for Phase I–III trials under ICH-GCP - protocol design, site and vendor selection, start-up, monitoring, data management, and inspection readiness.
Medical devices (MD): ISO 14155-compliant clinical investigations, clinical evaluation, and post-market evidence. Full EU MDR technical documentation (technical file, CER inputs, risk management, PMS/PMCF).
AI & digital health (incl. SaMD): Validation frameworks, study design, and real-world evidence plans for AI/ML solutions; covering data governance, performance metrics, human factors, and cybersecurity expectations across the EU, US, and Asia.
Regulatory & documentation: Study design advisory, submission strategy, and coordination with ethics committees, competent authorities, and notified bodies.
EU market access & distribution: Targeted introductions and partnerships with established distributors across the EU to accelerate commercial rollout.
Programme leadership: Integrated plans that optimise strategy, timelines, and budget, with transparent reporting and proactive risk management.
We work with
Start-ups & scale-ups with first-in-class medical devices, SaMD, or AI solutions
Biotech & pharma sponsors developing IMPs
Medtech manufacturers needing clinical evidence and MDR-ready documentation
Investors & incubators seeking execution support
Why Start-ups Choose Us
“We know the challenges because we live them ourselves. As active developers of solutions, we understand the realities of data access, model drift, clinical validation, privacy, and regulation. Empathy shapes how we design studies, stage budgets, and mitigate market entry risks.”
We conduct studies across Asia and the EU, leveraging on-the-ground expertise in Singapore, the United States, and multiple EU member states. This footprint lets us match the right investigators, sites, and distribution partners to each programme’s objectives.