ITK Engineering, a global tech company and subsidiary of Robert Bosch, which specialises in customised and cross-domain software and systems engineering, has announced its expansion into the UK. The EN ISO 13485-certified company will leverage its digital engineering expertise within one of the world’s most dynamic healthcare innovation ecosystems. The company has 30 years of experience in the field of smart healthcare solutions.
ITK Engineering says its entry into this market will provide innovators with high-quality engineering support for regulatory-compliant medical device development, embedded software and systems, robotics, AI-assisted engineering, cloud computing, and cyber security. The company says this support can help accelerate product development while ensuring regulatory compliance.
Dr. Frank Schmidt, CEO of ITK Engineering said: “The British market offers enormous potential for innovative healthcare solutions. With our extensive technology and methodological expertise, we are well-positioned to meet the needs of British medical device manufacturers.”
As the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) prepares to implement new post-market surveillance (PMS) requirements for medical devices on June 16, 2025, ITK Engineering says it is ready to assist manufacturers in navigating these changes. The new regulation, which integrate cyber security considerations for medical devices, underscore the growing importance of digital safety in healthcare.
This includes cyber security risk management, regular vulnerability scans, active CVE management, and swift implementation of security patches to address identified threats. By far the most important measure for ensuring cyber security in a medical device is cyber security risk management. However, experience shows that this is often not consistently pursued in projects – often for budgetary reasons. This is a false economy, as the result is high costs for the subsequent implementation of additional requirements.
ITK Engineering offers comprehensive support including cyber security risk management, CVE analytics, penetration testing, and standards-compliant documentation to help companies seamlessly integrate cyber security into their development and operational processes. This expertise is crucial as manufacturers need to adapt viewing cyber security as an integral part of their post-market responsibilities.
