Medical device, robot, virtual OR, or health cloud – as your engineering partner, we address every aspect of medical devices from hardware and embedded software to mobile cloud applications and data analytics with our interdisciplinary team.
Join and enjoy the journey to your medical system with ITK
We have the skills, methods, and firm grasp of trends to implement innovative solutions with you. What sets us apart is that our interdisciplinary teams are able to deliver turnkey systems from a single source. Be it a single component, an approvable product, or anything in between, your destination is all yours to determine.
Our services
Requirements engineering
A systematic approach to requirements engineering at the beginning of a project is the first stepping stone towards progress and the final gateway to success. With a firm grasp of methods and medical engineering skills honed over many years, we help determine, document, and verify the requirements for your system to spare you costly changes in later phases of the project. Call on us to
Determine stakeholder requirements
Develop manageable user stories
Draw up proof of concepts
Standards-compliant system development
With emerging new opportunities comes greater complexity. As your ISO 13485-certified partner for standards-compliant software and systems development, we lighten your workload by delivering innovation, architecture and security concepts, as well as standards-compliant solutions that are traceable all the way to the finished OEM product.
Certification marks the beginning of a new phase in a product’s lifecycle. Regular maintenance and updates are very much part of that lifecycle and have to be factored into the equation. Digital tools for application lifecycle management are required for the efficient application of processes throughout the entire product lifecycle. We will be happy to help you choose and use our advanced Polarion ALM modules.
Lifecycle management
Product updates
Maintenance & support
Quality assurance
Medical devices are subject to strict regulations. The new MDR sets out even more stringent rules in the interest of the highest priority, patient safety. We understand the importance of quality and have a great deal of experience complying with standards and regulations. As your go-to development partner, we are with you for the long haul, providing advice and operational support throughout the product lifecycle. Call on us to help you achieve your quality goals despite deadline pressure. Count on us to jointly develop your medical products to the latest standards. Let us clear every obstacle from your path to certification.
DIN EN 60601- 1:2013 medical electrical equipment safety
IEC 80001 security
IEC 61508 safety
Innovation
AI-assisted engineering in healthcare
Not so long ago, Generative AI began to reshape the way engineers develop systems and software for medical devices. Find out here how you can integrate AI assistants into your day-to-day development.
Cyber security check list for secure medical devices
Cyber security is not some voluntary exercise, it is a non-negotiable essential of the healthcare system’s digital transformation. Find out which activities are essential to protect your medical device from cyber attacks.
Virtual reality and augmented reality in healthcare
Virtual reality (VR) and augmented reality (AR) offer enormous potential to revolutionize healthcare. Already in the development of medical devices, virtual prototyping can reduce development risks, costs and development time.
State-of-the-art operating rooms exhibit a high degree of connectivity both between individual medical devices and within the hospital’s IT systems. OR integration solutions offer significant benefits in terms of improving operating room efficiency, cutting costs, and reducing administrative overhead.
Contrary to what many believe, this is not about cosmetics, about creating beautiful interfaces or sleek contemporary designs. It is about focusing on the core question: How do I build the product that it serves its purpose effectively and efficiently, yet still inspires and delights? Learn in our whitepaper what activities you should consider in the human-centered development process and how to engage real users right from the start.
Digital transformation in healthcare System development from a one-stop shop
As your engineering partner for tailor-made system development, we can help you turn your idea into an approvable product and provide continued support beyond its release. We value openness. We cultivate close relationships. And we are in this with you for the long term. Joining forces with you, we want to develop safe, connected healthcare solutions that benefit people and society as a whole.
Unsolved challenges? We look forward to your inquiry.