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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
EN ISO 13485
ISO 9001
ISO 27001
"Device networking on the Internet of Medical Things - Is always-on the only way?" and "Intelligent assistance systems in medical engineering"
"How to align test strategy and DevOps in largescale healthcare Systems"
