Technology & Trends

Beyond technical and regulatory considerations, cybersecurity failures can carry real business consequences. A single vulnerability can trigger expensive product recalls, unplanned remediation, and increased scrutiny from regulators and customers. Even more critical...

The Core Challenge: High Voltage in an Ultra‑Compact Space But size wasn't the only constraint. It’s crucial for a defibrillator that the capacitor maintains its charge over extended periods. Any significant leakage current could mean the difference between a...

What does usability engineering mean? In principle, usability engineering refers to the targeted analysis and development of the interfaces to the user. User interfaces are all points of interaction between the product and the user, or the patient. This includes...

Engineering and Integration Challenges in Miniaturized Systems The miniaturization of private-use diagnostic and therapeutic devices requires new approaches in mechanical design, electronics, thermal management, and system integration. It also demands close...

Connectivity is no longer a nice-to-have – it’s a prerequisite for market access and long-term viability. Anyone developing a medical device today must consider digital interfaces and secure data transmission from the outset. Given this context, the updated German...

The platform solution is fully scalable: we can quickly connect the customer’s existing technologies, such as sensors, to the system, both in terms of hardware and software. In close consultation with the customer, including hybrid customer and Corscience teams, our...

Risk management system Your processes must continuously assess and mitigate potential risks throughout the product lifecycle, from development to market surveillance. Manufacturers must ensure the reproducibility, reliability and safety of AI systems by regularly...

1. Conduct a comprehensive gap analysis The first step is to identify all AI components in your products and classify them according to the risk-based framework of the AI Act. In addition, are your existing technical documentation, risk management processes and market...

More regulation for more safety The AI Act is an additional regulation to the already strict requirements of the MDR. While the MDR focuses on the physical safety and well-being of patients and users, AI and machine learning raise new concerns. The AI Act addresses...

How does this affect practice? Clinical theory and practice of the MDR often diverge Early implementation of clinical aspects is underestimated Project cost explode due to lack of coordination with the notified body Insufficient clinical evidence for the general...