Services
Cybersecurity
We assess your current controls, perform penetration testing with healthcare scenarios, and define remediation plans aligned with NIST, IEC 62304, and ISO 14971.
Protect your medical software and data with HIPAA, GDPR, and FDA-aligned threat modeling, risk assessments, and secure architectures.
Quality
We design practical QMS processes, templates, and reviews so engineers can move faster while still generating audit-ready objective evidence.
Build robust software life cycles, verification strategies, and defect metrics tailored to Class II and III medical devices.
Delivery
From concept selection to market launch, we coordinate cross-functional teams in Costa Rica and abroad using lean, traceable project frameworks.
End-to-end project orchestration for regulated devices, integrating R&D, QA, and RA to hit milestones without compliance surprises.
SaMD
Leverage Costa Rica-based R&D to prototype, validate, and document SaMD solutions that satisfy FDA, EU MDR, and local regulatory expectations.
Plan and execute SaMD and AI/ML roadmaps, covering clinical evaluation, real-world monitoring, and change control for algorithms.
Services
Design
Architecture and requirements definition for medical software, with full IEC 62304 alignment and risk-based traceability to clinical use cases.
Verification
Risk-based verification and validation planning, test execution, and documentation that link requirements to objective evidence for global regulatory submissions.
Implementation
Implementation of compliant medical software, with coding standards, automated tests, and documentation integrated into an IEC 62304 lifecycle.
Costa Rica MedTech R&D | Leonardo Jimenez 