Medical Technology Solutions
Medical technologies demand high reliability, strict regulatory compliance, and fail-safe embedded systems. Our expertise ensures that devices operate safely and securely, mitigating risk for patients and manufacturers.
Competencies Overview
We leverage Product Safety, Cybersecurity, and Systems Engineering to design, validate, and certify medical devices. This includes ISO 14971 risk management, IEC 62304 software development, and cybersecurity best practices.
Approach / Methodology
Our methodology integrates safety analysis, verification, and validation into the development lifecycle. We assess hazards, perform risk mitigation, and guide teams on documentation for regulatory approval.
Case Studies / References
Product Safety
Cybersecurity
Industries / Sectors
Medical devices, diagnostic equipment, monitoring systems
Contact
Ensure your medical devices meet Product Safety and cybersecurity standards.