The new EU Battery Regulation was adopted in 2023 and is being phased in. Battery Regulation 2023/1542 can have a significant impact on medical technology, particularly on medical device manufacturers. It can lead to a complete redesign of the mechanics and electronics. ...
Why FPGAs in medical devices are increasingly becoming the focus of software audits and how you can avoid regulatory risks early on. When programmable logic suddenly ends up in a software audit, things can quickly become uncomfortable when the auditor asks you: "Where is your ...
05/14/2026
Many medical technology companies face the central challenge of transferring a developed medical device from development to series production – while complying with MDR, ISO 13485, and achieving full audit readiness. This is particularly true for prototype production, small-batch production, and early series production. ...
04/16/2026
Regional, traceable, resilient: Why MedTech is reinventing its supply chains. How geopolitical risks, dependence on China, and stricter regulations are fundamentally changing production and supply chain strategies in medical technology. Global MedTech supply chain at its limit. Imagine a medical technology company that previously faced ...
03/19/2026
In wireless distributed systems, each node runs its own hardware clock. Even identical embedded systems start with different time values, run at slightly different frequencies, and experience variable delays when sending, receiving, and processing data. Without synchronization, a ...
03/05/2026
Miniaturization in Wearables - Opportunities and Challenges for Hardware Development The beginning of vital parameter recording using wearables can be seen in Polar's fitness watches in the 80s, which could display circulatory data measured with a chest strap. ...
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