ITK Engineering, a global tech company and subsidiary of Robert Bosch, specialises in customised and cross-domain software and systems engineering, and it is excited to announce 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.
The UK has a thriving MedTech sector, with over 3,400 companies driving advancements in areas like AI-powered diagnostics, wearable medical devices, and robot-assisted surgery. ITK Engineering’s entry into this market will provide these 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. This support can help accelerate product development while ensuring regulatory compliance.
Dr. Frank Schmidt, CEO of ITK Engineering, states: “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.”
New requirements for post-market surveillance in the UK
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 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.
Invitation to connect: Meet ITK Engineering at Medical Technology UK
Visitors to Medical Technology UK 2025 in Coventry on 12th-13th March are invited to visit ITK Engineering at Stand 61. The company will showcase its engineering expertise and will be available for discussions about potential collaborations.
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