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 if the auditor asks you: ...
Classification of medical devices I, II or III
1, 2 or 3 is not only the question on a well-known quiz show for children on public television, but ...
News 2021 in the plastics world
From October 17th to 21st, international professionals met at Fakuma in the Friedrichshafen Trade Fair Center. With over 1,400 ...
BitFummler – Bit- uh – What?
Self-praise stinks! I agree. But in this case, it's not a problem, because due to the lack of browser-based smell support, there's... ...
Postmarket Cybersecurity – When the product is on the market
A product has been successfully approved and is on the market. Can cybersecurity activities now be discontinued? Absolutely. ...
Test scripts with Python Qt
Qt (like "cute" in English) is a C++-based framework of modules and libraries for cross-platform software development. ...
User Interface of unknown Provenance UOUP according to IEC62366-1
Medical devices have specific usability requirements. User errors can lead to harm to patients or operators. ...
Software risk management according to IEC 62304 and ISO 14971 – SW FMEA / FMECA for medical device software?
References: When IEC 62304 or ISO 14971 is mentioned below, the following editions are meant: IEC 62304:2006 + A1:2015 ...
AAMI TIR57 – Cybersecurity Risk Management for Medical Devices
Update Notice (May 23, 2025) This article is based on AAMI TIR57:2016, an important guideline for cybersecurity risk management in ...
What takes a long time finally becomes MDR
Over 2000 years ago, Ovid wrote, "What lasts long, will eventually be good." Sometimes it's also said, "Good things come to those who wait." ...
Calibration – DakkS or ISO?
Do you have your measuring instruments calibrated? Do you know what should be considered during the process? As part of our quality management system according to ISO 13485, we ...
Basic Git tips for efficient software development
Git is one of the most essential tools in software development. However, due to its enormous range of functions, there are also some features that, while ...
Leakproofness of medical devices
Leak tightness is a recurring issue in the development of (medical) devices. This is a topic that is often underestimated. ...
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