DIGITAL.

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.

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.

Medical device, robot, virtual OR, or medical cloud – whatever innovative solution you want to put into practice, we make the most of our methods, industry expertise, and firm grasp of trends and challenges to help you do it. What sets us apart: Our skill-set covers everything from hardware and embedded software to mobile cloud applications and data analytics. The bar is high in an industry where regulations are strict and development cycles short. Our innovations, architectures, and security concepts help you clear those hurdles – including standards-compliant solutions with full traceability right through to the finished OEM product.
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PRACTICAL ADVICE.

Comprehensive consulting on topics such as development, processes, security, and verification and validation.
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PRACTICAL ADVICE.

Digitalization is the driving force behind innovations in medical technology. We not only develop components and full-fledged solutions; we can also advise you on new business models and technologies that will gear your products up to get them connected. And we will be there for you throughout the development process with this motto in mind: What we advise, we can also provide.
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What we do at a glance:

  • Consult on ISO 13485:2016-compliant quality management
    1. Conduct ISO 13485:2012 vs. ISO 13485:2016 analyses
    2. Use the Medical SPICE assessment model
  • Support ISO 14971:2013-compliant risk management
    1. Determine risk policy and risk acceptance
    2. Conduct FTA to assess system architecture
    3. Document and link to development artifacts
  • Provide experiential advice on IEC 62304:2006 and A1:2015-compliant software development
  • Consult on cyber security:
    1. Analyze threats and vulnerabilities for/of medical devices
    2. Define and implement security concepts and protective measures
    3. Run security tests (protocol validation, penetration and fuzz tests)
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SECURE DEVELOPMENT.

Standards-compliant development throughout the lifecycle – from the feasibility study to the OEM product.
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SECURE DEVELOPMENT.

Embedded solutions, desktop applications, mobile apps – we furnish the complete software and system development package for diverse platforms to you. Functional security, cyber security, and efficient algorithms are top priorities alongside usability and standards-compliant development and documentation.
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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
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SMART VERIFICATION & VALIDATION.

Safeguarding complex medical software with security-critical functions in efficient, compliant ways.
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SMART VERIFICATION & VALIDATION.

Rising share of software, security-critical functions, and strict regulations: As medical devices get smarter, verification and validation grows more complex. We verify and validate your systems and tame complexity using tool chains alongside virtual and real-world methods.
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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
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STANDARDS-COMPLIANT DOCUMENTATION.

The right documentation paves a smooth path to certification in Europe (CE, MDR-compliant), the USA (FDA) and China (CFDA/SFDA).
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STANDARDS-COMPLIANT DOCUMENTATION.

To bring your medical devices to market securely and swiftly, they have to be fully traceable throughout the development process. Tailored to the demands of medical technology, our application lifecycle management tool serves to create documentation for approval authorities on the fly, during the development effort.
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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
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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.

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Saving lives with RescueWave®.

How ITK helps accelerate disaster response.

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.

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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
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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.

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Model-based development.

How ITK uses smart algorithms to control dental drills.

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.

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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
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Digital
therapeutics.

How ITK developed a personalized, app-based assistance system.

ITK Engineering teamed up with research partners to develop a personalized, app-based assistance system to treat people with bipolar disorders. Made of standards-compliant building blocks; the system helps patients through the day and provides doctors with indications that support ongoing therapy.

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Digital therapeutics.

How ITK developed a personalized, app-based assistance system.

Treatments tailored to the individual have the potential to mitigate suffering and enhance the patient’s quality of life. This app-based assistance system taps a treasure-trove of disease-related data collected in the course of the patient’s day-to-day life. Caregivers and relatives can also contribute their observations to this data pool. The valuable insights provided, assist the treating physicians or therapists in developing a more personalized treatment method. The app also benefits the patient by affording instant access to tips and first-aid measures.

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Our solution:

  • Work together with patients, therapists, and research and industry partners to develop user-centric applications, that factor in the need for personal privacy in a bid to boost transparency and acceptance
  • Drive the cross-platform development of mobile and web medical apps for patients, caregivers, relatives and therapists
  • Develop the backend with security and data privacy demands in mind
  • Develop algorithms and cognitive models, to eventually help forecast relapses
  • Connect medical devices and fitness wearables

We were able to fast-track development with standards-compliant digital health building blocks. A clinical trial is underway at Stuttgart Hospital to test this app-based assistance system.

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.
23.-24.10.2019 | MedConf  | Location: Munich, NH München Ost Konferenzcenter

"Device networking on the Internet of Medical Things - Is always-on the only way?" and "Intelligent assistance systems in medical engineering"

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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.
Visit us.
ITK Engineering GmbH
Im Speyerer Tal 6 | 76761 Rülzheim
Contact us.