As a certified software and system developer, we know all about bits and bytes. And we know that cyber security and data protection has to be built in from the start to support the digital transformation in healthcare.
DIGITAL.
INNOVATIVE.
Medical apps for prevention and rehabilitation can bring down health costs. But startups need a technical partner to help clear regulatory hurdles so they can quickly put their innovative digital health / eHealth ideas into action. We are that ally.
CONNECTED.
For more than 20 years, we have been developing software and systems for the medical and healthcare industries. We are connected and can put you in touch with the right technologies and partners for your digital healthcare offering.
HAND IN HAND FOR DIGITAL HEALTHCARE.
MUTUAL BENEFITS.
We want to work with you and other stakeholders to digitalize the healthcare market. You can count on us to be your technical expert.
MUTUAL BENEFITS.
What we bring to the table:
- More than 20 years’ experience developing medical devices (CE, FDA)
- The ability to develop standards-compliant software and systems
- The insight to provide regulatory consulting and technical advice
- Data science & analytics skills
- Connections throughout the industry
BUILT FOR APPROVAL.
Better digital care and lower healthcare costs – we help startups roll out innovative eHealth ideas with these objectives in mind.
BUILT FOR APPROVAL.
What we do at a glance:
- Provide regulatory advice and support
- Support series development and rollout
- Develop, implement, and test cyber security concepts
DATA-DRIVEN LEARNING.
Harnessing the power of data science and modern methods such as machine and deep learning, we gain new insights and develop innovative business models.
DATA-DRIVEN LEARNING.
What we do at a glance:
- Design and build machine learning applications with regulatory demands in mind
- Put image recognition and cognitive systems to use
- Employ smart data
- Protect and anonymize data
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.
Digital therapeutics.
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.
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.
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.
A partner in the medical industry.
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.
Our solution:
- Develop a suitable regulatory framework
- Jointly analyze quality management structures, review the product portfolio and the company’s set-up
- 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
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
EN ISO 13485
ISO 9001
ISO 27001