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. ...
08/08/2022
If you are certified according to DIN EN ISO 13485, or if that is your goal, you have probably already come across tool validation. Perhaps this article can help you and shed some light on the subject. Why do you need ...
01/10/2022
If you are also active in medical technology, then you have probably already noticed that EN ISO 13485:2016 has a new annex: EN ISO 13485:2016+A11:2021 Since we are also an EN ISO 13485 certified development service provider, we have ...
12/06/2021
Systems engineering is concerned with the development of a high-quality overall product. Usability engineering, on the other hand, aims to enable the user to complete their tasks efficiently and effectively. Despite and because of their different focus, both principles should be ...
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