COMPLIANT.

Count on us to help you develop and document products in compliance with IVDR/MDR standards. Benefit from the credentials and capabilities of a software and system development partner that has been ISO 13485-certified for many years and manages risk in compliance with ISO 14971.

CONNECTED.

Our technology skill-set and industry expertise enables us to connect lab, point-of-care and home-care devices with information security foremost in mind. We also excel at gearing up devices for web services such as remote diagnostics and maintenance and predictive maintenance.

SMART.

Rely on our holistic support to help you with your data strategy and data analytics, and vastly enhance diagnostic capabilities with the benefit of AI. We also draw on a deep well of automation and robotics expertise to develop smart diagnostic systems.

Automating and digitalizing diagnostic systems, delivering portable home diagnostic solutions.

Our experts are here to expedite your efforts to develop standards-compliant diagnostic solutions for the laboratory, point-of-care and home care. Let us work together to take diagnostics to the next level. How do we do this? By drawing on innovative technologies and methods. And by taking a big-picture view that extends beyond the application to encompass risk management.
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BUILT FOR APPROVAL.

Pursuing a standards-compliant approach to development throughout the lifecycle, from the feasibility study to the finished product, we clear every obstacle from the path to certification (IVDR/MDR, FDA, CFDA/SFDA). Once your product is certified, we can stay on board to provide maintenance and support.
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BUILT FOR APPROVAL.

Embedded laboratory devices, robotic assistance systems, portable POCT products, remote patient monitoring devices, digital diagnostics – we provide the full spectrum of software and system development services for a wide range of platforms. And all this is delivered to you from one trusted source.
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What we do at a glance:

  • ITK is certified according to:
    • ISO 13485 for product development, maintenance and servicing
    • ISO 27001 for information security
    • ISO 26262-8:2018 (ITK CI/CD tool chain)
  • ITK applies the following standards:
    • ISO 14971 for risk management
    • IEC 62304 for software development
    • IEC 62366 for usability engineering
    • IEC 60601 / IEC 61010 for system and hardware development
  • Application lifecycle management tools to ensure full traceability
  • Requirements engineering and concept studies
  • Platform development
  • Product maintenance services and support (updates, security monitoring)
  • On demand, ITK also:
    • Provides model-based development services
    • Applies SCRUM, Kanban and DevOps methods
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CONNECTING INFORMATION.

We connect your IVD devices to ensure information is accessible at every need-to-know point, with cyber security and data protection assured. Last but not least, this is relevant for post-market surveillance.
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CONNECTING INFORMATION.

Making good decisions is all about gathering data and taking readings. And the best decisions are reached when this information is accessed, compiled and presented in an intelligent way. Let us help you design and implement these connected diagnostic solutions. Information security and data protection are always top priorities in these projects.
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What we do at a glance:

  • Connecting devices:
    • Via interfaces (e.g. LAN, WLAN, Bluetooth, USB, CAN)
    • Via protocols (e.g. SDC/Continua, OPC UA)
    • To the cloud
  • Connection to HIS/PACS/LIMS/EMR systems: integration, communication and data transfer comply with HL7/DICOM/IHE/FHIR standards
  • Remote access for:
    • Device status checks (and traceability)
    • Remote diagnostics
    • Remote maintenance / updates
    • Predictive maintenance
    • Licensing
    • Post-market surveillance surveys and evaluations
  • AR/VR applications: display of relevant information and simulations for service, maintenance and training
  • Consideration of cyber security, information security and data protection (GDPR):
    • Cyber security by default, which includes security concepts, implementation and testing (the latter with CVE scans)
    • Privacy by design to protect and anonymize data
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AUTOMATING PROCESSES.

We develop automated solutions for your analytics workflows and apply our skills in control engineering, sensors, robotics, signal and image processing and machine learning to design intelligent diagnostic systems.
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AUTOMATING PROCESSES.

Control engineering, software development, control algorithms, mechatronics, system modeling – ITK has a very diverse skill-set. This broad spectrum enables us to look at complex challenges from various perspectives and see the system as a whole. With this knowledge, we can help you automate routine procedures and complex workflows that require exacting precision. This includes developing robotic assistance systems engineered for efficiency, accuracy and functional safety.
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What we do at a glance:

  • Automating routine procedures and complex workflows that require exacting precision
  • Robotic assistance systems (e.g. for pick & place) incl. robot integration and human-robot collaboration)
  • Control technology incl. sensors
  • Embedded and real-time systems
  • Functional safety
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Exploiting data potentials.

Connected diagnostic devices provide a wealth of operating data for analysis. Our data science, analytics and machine learning methods can help you put your data strategy into practice.
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Exploiting data potentials.

There are many good reasons to analyze data – to improve diagnostics as such, to discover unseen patterns and connections, to monitor quality, to protect against faults and failures with predictive models and to meet IVDR product surveillance requirements. We apply the latest machine learning, deep learning, object recognition, and perception and simulation methods to support your data strategy and analytics, all in service of your products and visions.
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What we do at a glance:

  • Consulting on how to best formulate your data strategy
    • Providing experts who know all about predictive analysis, profiling, monitoring and more to help put your vision into action
    • Advising on technologies’ capabilities and limitations with approvability in mind
    • Factoring the regulatory framework, certification, and risk and data management
    • Selecting methods, algorithms and tools for the given application and data quality
  • Realization
    • Processing and harnessing data in ways that let you make the most of your data sets
    • Delivering process-based (AI) development services that encompass everything from implementation, learning and model verification to documentation
    • Offering on-demand SOUP and tool validation services
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PRACTICAL ADVICE.

Why reinvent the wheel? Instead, why not benefit from our experience developing diagnostic and medical devices? Count on us to provide directions at the crossroads of regulations, engineering and development.
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PRACTICAL ADVICE.

The transition to MDR or IVDR is putting even more and bigger hurdles in medical device manufacturers’ path. Our advice on real-world issues is born of real-world experience. Complying with complex regulations while assuring efficient development is a balancing act, we have perfected in the space of 25 years. Fine-tuned interfaces and processes are the main ingredients in our recipe for success. Whatever your use case may be – a conventional device or a medical app – we can roll out and improve processes involving ISO 14971, IEC 62304, ISO 13485 and other standards. Application lifecycle management (ALM) tools are essential. These digital implements have to be up to date and tuned to manage processes efficiently from the cradle to the grave. We will be happy to help you choose and use our advanced Polarion ALM modules.
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What we do at a glance:

  • Consulting on IVDR/MDR and 21 CFR Part 820 and Part 11:
    • Implementing and optimizing QM/QA systems in compliance with ISO 13485
    • Risk management in compliance with ISO 14971:
      • Risk policy / acceptance based on the risk-benefit ratio
      • Risk management with top-down strategies such as fault tree analysis (FTA) and preliminary hazard analysis (PHA)
      • Risk analyses and the resulting safety architectures with risk mitigations and, if necessary, segregation
      • A roadmap for maintaining the post-market risk file
    • IEC 62304-compliant software development:
      • Risk-based test strategies and security architectures
      • Structured risk management for software
      • Comprehensive configuration management
    • Validating SOUP, COTS software and tools with risk-based, efficient methods
    • State-of-the-art cyber security (security analysis, concept, testing, advising on security engineering process)
    • IEC 62366-compliant usability engineering coordinated with the development and risk management process
  • Consulting on how ALM tools can support digital processes (e.g. tool selection, configuration, maintenance)
  • Polarion ALM medical modules, including configurations and templates adapted and implemented according to ISO 13485, ISO 14071, IEC 62366, DIN EN 60601-1:2013 to suit your processes and specifications
  • Selection and introduction of suitable development approaches (agile methods, DevOps) in the regulated area
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Partner for the Lab 4.0.

How ITK supports companies in developing solutions for the Lab 4.0.

Digitalisation of workflows, connecting devices and automation of processes will determine the laboratory of tomorrow. ITK supports companies with standards-compliant development, regulatory issues and maintenance.

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Partner for the Lab 4.0.

How ITK supports companies in developing solutions for the Lab 4.0.

More and more samples need to be analysed, evaluated and transmitted at high speed. Accuracy is also a key because errors have serious consequences. The digitalization and automation of processes in diagnostics is therefore an important prerequisite for mastering the complex processes, optimizing workflows and increasing efficiency. As an ISO 13485 certified healthcare engineering partner, we contribute to digitalization and bring intelligence to diagnostics. We support you throughout the standards-compliant development process of diagnostic solutions and help you to successfully implement your digitalization strategy.

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Our services:

    • Regulatory and security
      • IVDR, MDR, FDA, QM system ISO 13485, risk management, data privacy, cybersecurity
    • Standards-compliant device development
      • System, software, hardware/electronics, mechanics, automation, verification, design transfer, documentation (e.g. Polarion ALM)
    • Connected device
      • Interfaces (e.g. LAN, WLAN, bluetooth, CAN, USB), protocols (e.g. SDC/Continua, OPC UA), security (software & hardware), cloud
    • Remote maintenance
      • Device status, usage data, remote diagnosis, licensing, updates, predictive maintenance, data analytics/AI, service, PMS
    • Integration HIS/PACS/LIMS/EMR systems
      • Integration, communication and data transfer via HL7/DICOM/IHE/FHIR
    • Robot-supported assistance systems
      • Software, control algorithms, electronics and mechanics, safety, simulation
    • Intuitive operating & service concepts
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Explainable AI.

How ITK and the Japanese startup Hacarus have jointly developed an AI-based system for detecting anomalies in ECGs.

Artificial intelligence offers enormous potential to the healthcare system for improving diagnostics and therapy and can benefit patients and doctors to a great extent. In order to strengthen trust in AI-based medical systems, the protection of sensitive patient data must be ensured on the one hand and the decision-making process must be easy for doctors to understand on the other.

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Explainable AI.

How ITK and the Japanese startup Hacarus have jointly developed an AI-based system for detecting anomalies in ECGs.

ITK Engineering and the Japanese startup Hacarus have jointly developed a proof of concept for a personalized patient monitoring system, serving to evaluate ECG signals and taking safety, cybersecurity and data protection into account. The system not only evaluates anomalies in a single patient heart’s ECG in near real-time, but also provides at-a-glance comparisons with the expected normal ECG curve in the healthy state of the patient. The AI analysis requires only a few data sets and is visualized in a form that can be interpreted by doctors and supports them in fast and accurate judgement. ITK brought many years’ know-how in the areas of software and systems engineering, systems integration, device connectivity and cyber security to bear in this collaborative effort to develop this proof of concept.

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Our services:

  • ECG data analysis
  • Embedded software engineering
  • App development (iOS/Android)

Customer benefits:

  • Algorithm performs on edge devices and can be integrated into wearables
  • Results extracted from small data
  • Explainable AI creates trust and supports doctors
  • Assurance of highest standards patient safety, cyber security and data privacy as fundamental requirements for a CE or FDA approval of a medical device
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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.

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Simplify complex work processes.

How ITK enables intuitive control and management of laboratory equipment.

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.

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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
tuev-eniso_13485

EN ISO 13485

tuev-iso_9001

ISO 9001

tuev-iso_27001

ISO 27001

Come and get to know us.

Meet us at one of the following events and learn more about intriguing topics in our presentations.

We are always happy to assist you.

Interested in learning more? If so, or if you have questions about our services, please do not hesitate to get in touch with us.

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ITK Engineering GmbH
Im Speyerer Tal 6 | 76761 Rülzheim
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