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.
BUILT FOR APPROVAL.
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 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.
Invent. Implement. Innovate.
Partners on the path to your approvable medical device
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.
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.
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.
EN ISO 13485