BUILT FOR APPROVAL.

As an ISO 13485-certified software and system development partner, we overcome regulatory stumbling blocks and fast-track your time to the healthcare market with standards-compliant building blocks that mitigate risk.

SUCCESSFUL.

From an idea to a success story – let your startup benefit from 20+ years’ experience in medical engineering and a sharp technology skill-set. Take advantage of our support throughout the development process, from inceptive risk management to deployment in app stores.

FAST.

When we set out to develop eHealth solutions, mobile medical apps and the like, we do it with a passion for innovation, laser-like focus on results, and lean but standards-compliant processes. Cyber security, data protection, and regulatory issues are on our minds from day one so nothing will deter your successful market launch.

CONSULTING, DEVELOPMENT, APPROVAL: YOUR ONE-STOP SOURCE FOR THE FULL PACKAGE.

It’s time for innovation and experience to cross paths in the medical sector: We want to join forces with you to be part of the revolution in healthcare. Let us help you steer your business cases to success with our know-how, network, and firm grasp of standards.
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HOLISTIC SUPPORT.

Count on us to be there for you every step of the way, from the idea for a medical product to its approval in Europe (CE), USA (FDA) or China (CFDA/SFDA).
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HOLISTIC SUPPORT.

Standards, rules, regulations: The medical industry certainly has plenty of challenges in store for new digital health solutions. As a certified partner, we have the expertise to rise to the occasion. We accompany your product from inception to approval, managing risk, monitoring development, and supporting its launch on the healthcare market. You want to roll out your product swiftly and securely, with no unwelcome surprises. We think about data protection, cyber security, and regulatory issues early on to make sure that you do.
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What we do at a glance:

  • Provide regulatory consulting and support
    1. Manage risk in compliance with ISO 14971
    2. Build ISO 13485-compliant quality management systems
    3. Use efficient IEC 62304 / IEC 60601-1-compliant development processes
  • Support series development and rollout
  • Develop, implement, and test cyber security concepts
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DEVELOPED FOR APPROVAL.

Embedded software, desktop application or mobile app, we develop your digital health solution with approvability and usability in mind.
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DEVELOPED FOR APPROVAL.

Our support is all yours, at every stage of your efforts to develop embedded software, desktop applications, mobile applications, and wearables. Our top priority, first and always: your medical product’s approvability and usability.Time is money – and nowhere more so than in the world of digital health innovations. We accelerate your development with our IEC 62304-compliant backend and frontend building blocks. These modules readily adapt to your application, so you can build a prototype much faster and run user trials to test your idea at an early turn.
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What we do at a glance:

  • Develop frontends
    1. Mobile medical apps and responsive Web apps (IEC 62304)
    2. VR/AR applications
  • Develop backends
    1. With flexible setups: Cloud-based or on premise
    2. Cyber Security by default: Security concepts, implementation, and testing
    3. Privacy by design: Data protection and anonymization
  • Data science & analytics
    1. Machine learning applications, designed and built with regulatory demands in mind
    2. Image recognition and cognitive systems
    3. Smart data
  • Develop hardware for production in series
    1. Systems for medical wearables, companions, and digital diagnostics in compliance with IEC 60601-1
    2. Support the delivery of designs to manufacturing (QA support)
  • Rapidly adapt standards-compliant building blocks to your application
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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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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.

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A partner in the medical industry.

How ITK helps startups get ISO 13485-certified.

Standards, rules and regulations lay down the prerequisites in the digital health market; this poses a major challenge for startups. ITK Engineering provides advice and hands-on support to help newcomers gear up to certify their quality management systems to the ISO 13485:2016 standard.

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A partner in the medical industry.

How ITK helps startups get ISO 13485-certified.

Drawing on many years’ experience with medical technology and regulatory issues, ITK Engineering helps startups set up quality management systems in accordance with ISO 13485. Concrete recommendations for action and references based on our practical experience allow these fledgling companies to quickly and cost-effectively create the templates and artifacts needed to obtain certification.

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Our solution:

  • Develop a suitable regulatory framework
    1. Jointly analyze quality management structures, review the product portfolio and the company’s set-up
    2. Create a description of processes based on the company’s approach and procedures
  • Perform internal audits and conduct a gap analysis for ISO 13485 certification
  • Support efforts to adopt DIN EN 62366 usability and DIN EN ISO 14971 risk management standards
  • Share practical tips and tricks to help align software development with IEC 62304 and IEC 60601-1

 

Startup benefits:

  • Deep well of industry experience to draw on
  • Less money and time spent on preparing for certification
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.