Engineering Services for Connected Medical Devices

Built for Performance. Designed for Compliance.

From board-level code to AI-ready cloud — one engineering partner for your entire product lifecycle.

End-to-End Engineering

Compliance Built-In

Faster Time-to-Market

Trusted MedTech Partner

Device Management

AI Integration

End-to-End Tech for Your MedTech Product

We support manufacturers at every phase — from first prototype to global deployment.

Medical Grade Software

Developed under ISO 13485 & IEC 62304.

Embedded Software Development

STM32, ESP32, Zephyr, FreeRTOS, SafeRTOS.

Cloud Hosting & Infrastructure

ISO 27001-certified, sovereign or private hosting.

Connectivity & Regulatory Consulting

MDR, IVDR, FDA, IEC 81001-5-1.

Cybersecurity Consulting

Threat modelling, encryption, OTA updates.

MedDevOps

CI/CD pipelines adapted to regulatory frameworks.

Information Security Consulting

ISMS planning, supplier audits, ISO 27001 alignment.

Designed for MedTech Standards

From architecture to audit — every deliverable is built with compliance in mind.

Complete documentation sets (DHF, risk assessments, usability files)

Software lifecycle files according to IEC 62304

Risk management aligned with ISO 14971

Secure system design (ISO 81001-5-1)

Privacy-by-design architecture (ISO 27701 & GDPR)

Hosting & operations under ISO 27001

From Prototype to Global Scale

We provide the right building blocks for every phase of your MedTech product lifecycle.

Prototype

Quickly validate concepts with real data flows using our mdeg ConnectBox and pre-configured cloud. Ideal for MVPs, feasibility studies, and investor demos.

Clinical

Deploy secure, role-based environments with audit trails and pseudonymisation — ready for ethics committees, hospital IT, and pre-market studies.

Market

Launch with full IEC 62304 / ISO 13485 documentation, CI/CD pipelines adapted to regulatory needs, and production-grade hosting in EU/US/CH/UK.

Scale-up

Expand globally with compliant multi-region hosting, ongoing feature development, AI integration, and scalable infrastructure aligned with MDR, IVDR, and FDA requirements.

Our Engineering Process

A structured process that combines engineering speed, regulatory compliance, and long-term partnership.

Kick-off & Discovery

Joint workshops to align on goals, scope, and regulatory context.

Architecture & Planning

We define the system design, roadmap, and documentation plan.

Implementation

Agile delivery with embedded QA, DevOps, V&V, and compliance checks.

Handover or Hosting

Choose between internal handover or fully managed hosting by us.

Long-Term Support

Ongoing updates, maintenance, audits, and recertification support.

Certifications & Tools

We speak your auditor’s language — modern tools, documented for compliance.

Version Control & Traceability

GitLab / GitHub / Azure DevOps with audit-ready histories.

Automated QA & Security

CI/CD pipelines, static code analysis, vulnerability scanning.

Test & Coverage Reports

Structured test documentation and coverage metrics.

Cloud Monitoring & Alerts

Lifecycle logs, dashboards, and compliance tracking.

Regulatory File Structure

IEC 62304, ISO 13485, MDR-aligned documentation packages.

What Makes Us Different

Engineering meets product thinking — we don’t just write code, we help you launch successful MedTech products.

Proven Modules

ConnectBox, mdeg Cloud, and CI/CD pipelines — tested and ready to accelerate your launch.

Complete Documentation

No gaps, no excuses — we deliver full, audit-ready documentation for every project.

Private Cloud Hosting

Dedicated environments by default — secure, compliant, and never on shared AWS/Azure.

Regulatory Alignment

Solutions built for MDR, IVDR, FDA, GDPR, and HIPAA compliance worldwide.

Unified Expertise

Embedded engineers and cloud specialists under one roof — faster, smoother delivery.

Trusted by Innovators

Chosen by heart pump makers, implant providers, AI start-ups, and diagnostics leaders.

Launch Your MedTech Product with Confidence

From prototype to global deployment — mdeg ensures speed, compliance, and long-term support.

Karl Larsson

Managing Director | Aligned AG

mdeg provided not only timely and valuable insights in the procedural documentation but also, most important of all, concrete, detailed suggestions on the implementation level, never taking his focus off our small business context, both from a financial and effort perspective.

Dr. Markus Windolf

CEO | Founder, BIOS Medical

mdeg’s Starter Kit surpassed our needs, providing innovative features that elevated our project to the next level