Mechatronic AG
Engineering company based in Darmstadt, Germany, providing end-to-end medical-device engineering: system-level device development, electronics and embedded software, production readiness and series manufacturing, regulatory/authorization support for international markets, and product life-cycle management. Works on custom projects across diagnostics, treatment devices and clinical systems, and offers modular services from early-stage concept to authorized series devices. Maintains documented data-protection and website security practices consistent with applicable EU data-protection requirements.
Industries
Nr. of Employees
medium (51-250)
Products
In-line blood analysis monitor (continuous blood-monitoring unit)
Development of a continuous in-line blood analysis monitor for monitoring blood parameters during extracorporeal circulation; included mechanics, embedded electronics, software and lifecycle services.
Self-calibrating compact spirometer system
Development of a self-calibrating, compact spirometer system including main unit and sensor unit with connectivity, EMC compliance and contactless charging.
Prototype integration for a proton-beam treatment unit
System integration, prototype build, safety and automated test implementation for a custom proton-beam treatment unit used in eye-tumor therapy.
Manufacturing and qualification support for cardiovascular device
Testing, optimisation and establishment of production processes and test equipment for a coronary sinus impulse therapy system to achieve regulatory readiness for series production.
GAST (Generic Automatic System Tester)
A unique, modularly constructed testing platform designed to quickly and cost-efficiently adapt test methods and custom-built test benches to project frameworks.
Luxury PlasmaLiner
A high-quality plasma device for the cosmetic-aesthetic sector, utilizing atmospheric soft plasma for professional skin treatment against wrinkles, skin blemishes, and hair therapy.
In-line blood analysis monitor (continuous blood-monitoring unit)
Development of a continuous in-line blood analysis monitor for monitoring blood parameters during extracorporeal circulation; included mechanics, embedded electronics, software and lifecycle services.
Self-calibrating compact spirometer system
Development of a self-calibrating, compact spirometer system including main unit and sensor unit with connectivity, EMC compliance and contactless charging.
Prototype integration for a proton-beam treatment unit
System integration, prototype build, safety and automated test implementation for a custom proton-beam treatment unit used in eye-tumor therapy.
Manufacturing and qualification support for cardiovascular device
Testing, optimisation and establishment of production processes and test equipment for a coronary sinus impulse therapy system to achieve regulatory readiness for series production.
GAST (Generic Automatic System Tester)
A unique, modularly constructed testing platform designed to quickly and cost-efficiently adapt test methods and custom-built test benches to project frameworks.
Luxury PlasmaLiner
A high-quality plasma device for the cosmetic-aesthetic sector, utilizing atmospheric soft plasma for professional skin treatment against wrinkles, skin blemishes, and hair therapy.
Services
End-to-end development of medical and diagnostic devices covering system architecture, mechanics, electronics and software.
Production setup, test-station development, pilot series and series manufacturing support for medical devices.
Preparation and handling of regulatory submissions, certification process management and liaison for international approvals.
Verification planning and execution including EMC testing, mechanical drop testing and conformity verification to medical standards.
Change and obsolescence management, second-level service and redesign for device maintenance and successive product editions.
Design and implementation of medical software stacks, device-cloud connectivity and IoT integrations.
End-to-end development of medical and diagnostic devices covering system architecture, mechanics, electronics and software.
Production setup, test-station development, pilot series and series manufacturing support for medical devices.
Preparation and handling of regulatory submissions, certification process management and liaison for international approvals.
Verification planning and execution including EMC testing, mechanical drop testing and conformity verification to medical standards.
Change and obsolescence management, second-level service and redesign for device maintenance and successive product editions.
Design and implementation of medical software stacks, device-cloud connectivity and IoT integrations.
Expertise Areas
- System-level medical device development
- Medical device manufacturing and production readiness
- Regulatory affairs and international authorization support
- EMC, conformity and verification testing
Key Technologies
- Embedded systems (microcontrollers, embedded PCs)
- C++ and Linux/Windows application stacks
- Wireless and wired device connectivity (cellular, WLAN, Bluetooth, USB)
- EMC testing and medical electrical safety standards
News & Updates
Company displays ISO 9001 certification on its site (image shown).
Company displays ISO 13485 certification for medical device quality management (image shown).
Company displays ISO 9001 certification on its site (image shown).
Company displays ISO 13485 certification for medical device quality management (image shown).