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 digital health applications, 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, mobile app or digital health application, 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, digital health applications (DiGA) 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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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
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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Flexible and secure into the cloud.

How ITK developed a modular microservice infrastructure for a medical device.

What does it take to make complex system architecture for a medical device highly scalable, flexible and secure? ITK delivered the goods when a digital health startup asked the company to develop a modular microservice infrastructure that can be hosted on-premise or in the cloud.

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Flexible and secure into the cloud.

How ITK developed a modular microservice infrastructure for a medical device.

Tasked to design modular system architecture, ITK Engineering came up with a scalable microservice infrastructure for a standards-compliant epileptic seizure detector that meets the highest security requirements. ITK also developed the web interface. It connects to the backend to furnish information and statistics on patient’s epileptic seizures to the physician. Brought on board as a development Partner, ITK Engineering took a holistic view of the overall system to support requirements and risk management from day one. The company also shared ist regulatory know-how regarding quality management and usability engineering.

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Our solution:

  • Developing a REST-based interface concept to integrate backend, frontend and mobile app.
  • Building a backend based on a microservice architecture with Docker containers
  • Engineering a frontend based on Angular and featuring a modified Angular calendar component to handle the seizure log

Customer benefits:

  • Solution provides approvable and reusable microservices (user and physician interface, device management, user administration, data management, authentification gateway, notification service)
  • Highly scalable design accomodates many functions, users and large amounts of data
  • State-of-the-art security e.g. protection of patient data through authentification and encryption
  • Remarkably flexible – it adapts dynamically to changing requirements engineering scenarios
  • Modular architecture for easy maintainability and extensiblity
  • Flexible hosting model: on-premise or via SaaS
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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.

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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