New opportunities, rising complexity: As an ISO 13485-certified partner for standards-compliant software and system development, we are here to lighten your workload and tackle your complex digital challenges.
DIGITAL.
SECURE.
Building on our expertise in functional and cyber security, we make sure your medical product is protected. And as an ISO 27001-certified partner, we do the same for your information.
CONNECTED.
With more than 20 years in medical engineering, we have a deep well of experience to draw on. Our cross-sector know-how extends from Industry 4.0 to building services engineering. The end-to-end expertise to connect your medical products and bring new business models to life is within your reach.
FROM EMBEDDED SYSTEM DEVELOPMENT TO WEB APPLICATIONS AND MEDICAL APPS.
Mastering complexity.
Our team of control engineers, software developers, system architects and mechatronic engineers has all the competencies we need to deliver smart robots and assistance systems.
Mastering complexity.
What we do at a glance:
- Kinematics, dynamics and motion planning
- Motor control and sensor technology
- Embedded and real-time systems
- Navigation for mobile robot systems
- Image processing
- Cognition, autonomy
- Collaborative operating concepts
- User interfaces, dialog systems
- Functional safety
- Teleoperation, haptic feedback
- Remote diagnostics and maintenance
- Cloud connectivity, cyber security
- Training systems
- Support for service operations
- Virtual prototyping
PRACTICAL ADVICE.
Comprehensive consulting on topics such as development, processes, security, and verification and validation.
PRACTICAL ADVICE.
What we do at a glance:
- Consult on ISO 13485:2016-compliant quality management
- Conduct ISO 13485:2012 vs. ISO 13485:2016 analyses
- Use the Medical SPICE assessment model
- Support ISO 14971:2013-compliant risk management
- Determine risk policy and risk acceptance
- Conduct FTA to assess system architecture
- Document and link to development artifacts
- Provide experiential advice on IEC 62304:2006 and A1:2015-compliant software development
- Consult on cyber security:
- Analyze threats and vulnerabilities for/of medical devices
- Define and implement security concepts and protective measures
- Run security tests (protocol validation, penetration and fuzz tests)
SECURE DEVELOPMENT.
Standards-compliant development throughout the lifecycle – from the feasibility study to the OEM product.
SECURE DEVELOPMENT.
Making the most of conventional methods such as model-based development and innovative, agile techniques such as SCRUM, DevOps and continuous integration, we tame the complexities of connected medical technology for you.
What we do at a glance:
- Conduct requirements engineering and concept studies
- Develop software in compliance with IEC 62304
- Develop system and hardware series in compliance with IEC 60601-1
- Manage risk in compliance with ISO 14971
- Assure usability in compliance with IEC 62366
- Provide product care and maintenance services
- Develop platforms
SMART VERIFICATION & VALIDATION.
Safeguarding complex medical software with security-critical functions in efficient, compliant ways.
SMART VERIFICATION & VALIDATION.
Intelligent test strategies with automated, reproducible and efficiently managed tests enable us to detect and avoid errors at an early turn.
What we do at a glance:
- Manage tests and develop testing strategies
- Verify & validate every step of the way (MiL, SiL, PiL, HiL)
- Integrate continuous tool chains
STANDARDS-COMPLIANT DOCUMENTATION.
The right documentation paves a smooth path to certification in Europe (CE, MDR-compliant), the USA (FDA) and China (CFDA/SFDA).
STANDARDS-COMPLIANT DOCUMENTATION.
There will be no unwelcome surprises when it comes time to get software approved and rolled out on the medical engineering market.
What we do at a glance:
- Manage application lifecycles
- Assure end-to-end traceability
Saving lives with RescueWave®.
How ITK helps accelerate disaster response.
ITK Engineering GmbH joined forces with VOMATEC Innovations GmbH and answerING Beratende Ingenieure PartGmbB to develop RescueWave®. Our efforts focused on developing an IoT network with a dedicated radio protocol and the Rescue.Nodes as an electronic triage device.
Saving lives with RescueWave®.
Rapid intervention forces are crucial in the event of a disaster. Mere minutes can make all the difference, especially in unclear circumstances of a mass casualty situations. Until now first responders categorize patients with color-coded triage tags. However, these paper tags make it difficult for the command and control team to generate a structured operational plan for rescue forces; since It takes time to get an accurate picture of the situation. RescueWave® helps by providing situational information and facilitating rescue forces’ efforts to register patients and organize transport.
Our solution:
- Develop a turnkey product (Rescue.Node) including the firmware, hardware and manufacturing coordination
- Design the device with usability in mind
- Build an energy-saving, robust IP54 protection-class device with four hours operating time, a range of several kilometers at -20 to +60 °C, and a one-year maintenance cycle
- Integrate GPS and other sensors to precisely pinpoint the patient’s location
RescueWave® is an innovative system that solves the most difficult problems of the chaotic phase — that takes place at the beginning of every mass-casualty incident — in one fell swoop: to gain a clear overview.
Emergency Physician Dr. Matthias Wölfel
District of Germersheim, Germany
Model-based
development.
How ITK uses smart algorithms to control dental drills.
More reliable, smaller and easier to clean, sensorless and brushless DC (BLCD) motors are perfect for dental drills. On the downside, it takes a lot more effort to develop a control system because of the complex algorithms involved. ITK found a way to lighten this workload with model-based development.
Model-based development.
Sensor and brushless DC (BLCD) motors are ideal for dental drills. They are hard-wearing, more reliable, and quieter and easier to maintain and clean than motors with brushes. Sensorless BLCD motors’ compact design and low price are also strong selling points. Their one drawback is that developing complex algorithms for sensorless controls involves a lot more work.
Our solution:
- Design and optimize a rotor position estimator and a complex cascade control for an IEC 62304-compliant dental drill motor
- Develop control software and motor hardware parallelly using Simulink® and Stateflow®
- Run closed-loop simulations of the plant model with and without rotor position signals to allow the controller and position estimator to be developed independently of one another
- Conduct automated module tests for individual components based on MATLAB scripts
Customer benefits:
- Model-based development delivered results in half the time
- Prototype served to pinpoint hardware problems at an early turn
Simplify complex work processes.
How ITK enables intuitive control and management of laboratory equipment.
How to efficiently monitor a multitude of devices with complex functions? ITK has developed a customer-specific software solution for laboratory equipment that enables the intuitive management and execution of measurement and control tasks in a modular user interface.
Simplify complex work processes.
User-friendly and intuitive – ITK Engineering has developed a new device management software solution for a laboratory equipment manufacturer to control connected devices for applications in scientific and industrial laboratories. The user interface provides a quick overview of all connected devices and their measured values in real time. Devices can be configured remotely and inconsistencies can be quickly located and corrected. The analysis tool documents and exports all data at the push of a button.
Our solution:
- Connection of existing devices from the product Portfolio and selected third-party devices
- Creation of a room planning module for the localization of the devices
- Live notification of events/alarms on the devices and live display of physical parameters
- Program Manager for the creation of planned physical processes on the devices
- Integration of moder I4.0 protocols, for example for predictive maintenance
- Integration of a multi-Level licence model for sales support for different customer groups
Customer benefits:
- Implementation of a large functional spectrum with the help of agile development methods
- User-friendly and intuitive operation
- Modular architecture ensures maintainability and expandability
EN ISO 13485
ISO 9001
ISO 27001