Traditionally, EMC testing of medical devices focuses on basic safety and essential performance. But what about functions that, while not directly safety-critical, nevertheless play an important role in clinical application? This is precisely where this approach comes in. ...
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 ...
12/01/2025
I frequently read articles that cite IEC 60601-1-2 as the sole EMC requirement for medical devices. However, anyone who believes that IEC 60601-1-2 covers all EMC requirements for medical devices may be overlooking something. Here's why. When is IEC ...
Why EMC testing is vital in medical technology: Imagine a patient is in the hospital during critical monitoring. Suddenly, a visitor's smartphone rings – and the monitoring device suddenly displays errors or delivers corrupted data. ...
To ensure high product quality and customer satisfaction, quality problems must be identified, analyzed, and resolved early. CAPA is a proven tool to help companies identify and eliminate the causes of quality deviations. ...
10/31/2022
In medical technology, technical errors in a device can have fatal consequences for operators or patients. Therefore, a safety architecture is generally required during the approval process for medical devices. It is important to consider the issue of functional safety right from the design stage. ...
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