Build
Build your new medical product through a structured process and in full compliance with regulatory requirements. Develop trusted, safe, AI-powered medical solutions supported by precise quality management and complete regulatory documentation.
Our Expertise
Product Development & Engineering
Architecture Design and Cloud Infrastructure Planning. End-to-end software engineering for health platforms. Sprint-based agile delivery with full transparency, microservices, and CI/CD pipelines.
SaMD Development
Software Risk Management and Regulatory Documentation under ISO14971. Design and development under MDR (EU 2017/745), FDA 21 CFR Part 11, and IEC 62304. Predicate analysis and software verification.
Embedded & Connected Device Software
Over-the-Air Updates and Hardware Abstraction Layers. Real-time embedded software for regulated hardware (ARM Cortex, RTOS). Bluetooth LE, Wi-Fi, NFC, and cellular integration. Secure boot.
Patient-Facing & Consumer Health Applications
Clinical-Grade Usability for Chronic Disease Management. End-user apps for telehealth, remote patient monitoring, and wellness. Integration with wearables and consumer health devices. CE/FDA pathway assessment.
Regulated AI Product Development
Regulatory Submission compliance from Day One. Build of AI-enabled SaMD and SiMD. EU AI Act conformity, human oversight, training data governance, bias assessment, and algorithm explainability.
Quality Management & Regulatory Documentation - Build Phase
Requirements and SDP Authored Prior to Development. Embeds quality and regulatory documentation from day one. ISO 13485:2016 alignment, live traceability matrix, hazard analysis, and usability file.
AI-Assisted Delivery Across the Build Tier
AI Coding Assistants Governed by Human Review. We use AI for architectural drafting, test generation, and documentation to accelerate routine work while ensuring direct human oversight and approval of every outcome.
Partner with Thaumatec - Medtech Software Experts
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