Medtech & Healthcare

Medtech & Healthcare - Precision-Driven, Compliance-Centred Engineering

At Qubist Solutions, we deeply understand the critical nature of healthcare systems. Our expertise in ISO 13485 and IEC 62304–compliant software development ensures precision, reliability, and patient safety from requirement definition through deployment and maintenance.

What We Deliver

Embedded Medical Systems

Design and implementation using C/C++ and Java, tailored for embedded hardware in medical devices—such as infusion pumps, imaging systems, and wearable health monitors.

Regulatory & Functional Safety

Comprehensive compliance with HIPAA, IEC 62304, ISO 14971 (risk management), ISO 13485 (quality systems)—ensuring patient data protection, audit readiness, and risk-mitigated solution delivery.

Model-Based System Engineering

Efficient system validation with MATLAB/Simulink and Model-Based Design, enabling early-stage simulation for clinical study tools, predictive analytics, and digital therapeutics.

Automated Testing & Quality Assurance

Robust unit, integration, and regression testing; continuous compliance audits via code coverage, traceability matrices, and CI/CD pipelines under FDA-aligned practices.

Cloud & Data-Driven Analytics

Secure management of medical data in compliance with GDPR, HIPAA, and ISO 27001; AI/ML-powered insights—like predictive analytics for diagnostics, image analysis, and data-driven care workflows.

Interoperability & Standards

Seamless integration via HL7, FHIR, DICOM, LOINC—facilitating interoperability with hospital systems, EMRs/EHRs, and diagnostic instruments.

Why Qubist Stands Out

• Compliance at the Core: We embed safety and regulatory adherence into every phase—empowering your path to market with audit-ready, quality-driven software.
  
  

• Full-Cycle Engineering: From ideation and prototyping to deployment and validation, our teams deliver full-spectrum software solutions tailored to medical environments.
  
  

• Cross-Industry Innovation: Applying insights from automotive, avionics, IoT, and rail to elevate reliability, efficiency, and innovation in healthcare software systems.
  
  

• Agile, Flexible Collaboration: Whether it's embedded system development, cloud-based applications, or AI modules, our engagement adapts to your project needs—team augmentation, turnkey delivery, or co-development models.
  
  

• Outcome-Focused Approach: Beyond delivering code, we aim to impact care—improving diagnostics, optimizing operations, and ultimately elevating patient outcomes.