Compliance Assurance for HealthTech & Medical Software
Regulatory compliance should support innovation — not slow it down. We integrate MDR, FDA, IEC 62304, ISO 14971, and cybersecurity requirements into your product architecture and development process from day one.
In MedTech, compliance determines whether your product reaches the market. We support founders and product leaders in designing, validating, and structuring medical software and connected devices in line with regulatory requirements. Our approach reduces risk, limits costly rework,and strengthens certification readiness from the earliest stages of development.
Our Expertise
Regulatory Strategy & Gap Analysis
Secure & Compliant Architecture
Documentation & Audit Readiness
Medical Software Compliance Audits
Is Your Product Truly Audit-Ready? Let’s evaluate your compliance strategy before regulators do.
AI-Driven Light Therapy Platform
We leverage our expertise in AI, connectivity, and prototyping to develop a smart well being AI powered platform. The goal is to optimize the body’s natural circadian rhythm through data-driven light therapy, turning complex bio-analytics into a seamless tool for health.
Patient Monitoring Arm Band
For our client, we power care delivery through specialized monitoring software. This solution enables providers to enhance patient life, reduce costs, and accelerate medical response. We deliver the intelligence driving systemic efficiency.
Laboratory AI video platform
For our client, a German startup, we developed an AI-driven video platform for automated analysis of mouse behavior in laboratory environments. The solution uses computer vision and machine learning to detect animals, track movement patterns, and support advanced behavioral research.
Tell us about your project
Contact Us
office@thaumatec.com
