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...
Some examples of safety related errors found include Incorrect ventilation or no ventilation at all Missing or incorrect alarm output, e.g. due to a speaker failure Startup in password protected mode, allowing unauthorized persons to make critical changes Problems...
What Exactly Is It? This patented invention describes an innovative method for measuring gas samples in a sidestream with the highest temporal resolution. The technology enables precise analysis of the gas composition in flowing gases or gas mixtures and is ideally...
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...
The task We were approached by a customer with a request to develop a new vital signs monitor recording among others the following measurements: heart rate and arterial oxygen saturation with optical methods; body temperature with an infrared thermometer; blood...
My main aim was to gain practical experience in software development and, at the same time, learn more about the current state of defibrillator development. During discussion with my team, one aim really came to the fore: to improve and expand speech recognition for...
What actually is functional safety? A medical device malfunctioning can be the difference between life and death. Therefore, the aim has to be that the device works reliably and that technical faults that may cause a danger are quickly detected, and countermeasures...
Robert, is this issue on the industry’s radar, or is it now catching many companies off guard? It chiefly depends on the size of the company, in my opinion. Big companies are usually already aware of this problem, and are either setting up internal structures or have...