Medical Device Engineering & Consulting
Cortex MedTech is a boutique consulting and engineering house for medical devices. We design the system architecture, build the regulated software, and run the quality system that governs both. A small, senior team, working alongside yours.
Services
Medical device programs rarely stall inside a discipline. They stall in the gaps between them, where the system concept meets the software, or where the software meets the quality system. We cover all three in one toolchain, so those gaps never open.
We turn clinical intent into a technical concept you can build and defend: system architecture, requirements, risk analysis, technology selection, and feasibility work. From first concept through design freeze, with the trade-offs documented in a form that carries straight into your design history file.
Regulated software, written by the people who designed the architecture. Embedded and application software, image processing and AI/ML components, cloud and data infrastructure, all developed under IEC 62304 with the verification evidence produced along the way, not reconstructed before an audit.
Quality systems that work the way engineering does. ISO 13485 processes, risk management to ISO 14971, and usability to IEC 62366-1, delivered as a Git-native eQMS that lives in your repository and runs on your CI, set up and managed by us.
Engineering and compliance are not two projects. We run them as one.
Company
Cortex MedTech is a small engineering house near Munich. Deliberately small: the people you meet are the people who do the work. Our background spans surgical robotics, endoscopy, medical imaging, and regulated software development at both startups and established manufacturers, which means we have sat on both sides of the table in design reviews and audits.
We work as an extension of your team, on engagements from a focused architecture review to full ownership of a workstream through design transfer.
Based in Ottobrunn, near Munich.
Contact
Scoping a new system, short on senior engineering capacity, or with an audit on the horizon? Happy to talk it through. No pitch deck required.