370 people per day – that's how many suffer a sudden cardiac arrest in Germany according to the German Resuscitation Registry 2024. That's over 136,000 cases per year, mostly outside of hospitals [1]. The good news: More and more people ...
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. ...
Testing with PCAN Explorer
PEAK-System's PCAN Explorer software enables the sending, monitoring, and evaluation of messages on an internal CAN (Controller Area) bus. ...
Event tip: Modeling for Everyone – Consistent model-based development
ⓘ This event has already ended. Summary Topic: Modelling for Everyone Date: April 28, 2021, from 6 PM to 8 PM Location: Online ...
FDA Cybersecurity Approval Guidelines
Anyone wanting to get a medical device approved in the USA must go to the Food and Drug Administration (FDA – the agency for approval). ...
Low latency with Bluetooth Low Energy
Bluetooth Low Energy (BLE) has become the communication standard for energy-efficient wireless communication in recent years. ...
Usability engineering for medical devices
Introduction What makes a good product? Before my time in software engineering, I personally always thought that the requirements ...
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