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
We assess your product against applicable standards (MDR, IVDR, FDA, IEC, ISO) and identify compliance gaps early — before they become costly risks.
Secure & Compliant Architecture
We design system architectures aligned with IEC 62304, ISO 14971, IEC 80001-1, and cybersecurity best practices.
Documentation & Audit Readiness
We prepare and structure technical documentation, traceability, and evidence required for audits and certification.
Medical Software Compliance Audits
We conduct internal audits and readiness reviews to ensure your product is prepared for notified bodies and regulatory submission.
Is Your Product Truly Audit-Ready? Let’s evaluate your compliance strategy before regulators do.
Selected success stories
ISO and IEC Medical Device Consulting
We supported a HealthTech company in assessing their medical software against MDR, FDA, and IEC 62304 requirements. Our structured gap analysis identified compliance risks early and strengthened certification readiness.
Get in touch, let’s discover the solution together
Contact us
office@thaumatec.com
+48 698 632 801
Thaumatec Sp. z o.o.
ul. Joachima Lelewela 853-505 Wroclaw, PolandVAT-ID/NIP: PL897-179-80-51
Thaumatec IoT Cloud Sp. z o. o.
ul. Joachima Lelewela 853-505 Wroclaw, PolandVAT-ID/NIP: PL897-187-43-03
Thaumatec Nederland B.V.
Kastanjelaan 400,5616 LZ EindhovenKvK nummer: 34257476