When requirements start to become fragmented... The larger and more complex a medical device development project becomes, the more information is generated. Requirements are documented, technical decisions are recorded elsewhere, and tests are documented in... ...
STRIDE in medical technology – Cybersecurity risk analysis according to IEC 81001-5-1
Cybersecurity is no longer seen as an option in medical technology. It's mandatory. This was made clear at the latest by IEC 81001-5-1 and the... ...
Usability in Embedded Development: How good debug interfaces save developers and testers time and frustration
Usability is generally highly valued – yet it is still often neglected. Why is that? Because usability is often ...
What IEC 81001-5-1 means for medical device developers
Cybersecurity is mandatory. EU Regulation 2017/745 (MDR) requires that medical devices be protected against unauthorized access. For manufacturers of medical devices and ...
SysML v2 for operating room lights
Variety of variants and integration pressure: The invisible bottleneck for operating room lights SysML v2 is becoming increasingly important, as operating room lights today are highly complex, mechatronic ...
EMC for medical devices: Why IEC 60601-1-2 alone is not sufficient
I keep reading articles that cite IEC 60601-1-2 as the sole EMC requirement for medical devices. But anyone who believes that ...
What does EMC mean for medical devices in practice?
Why EMC testing is vital in medical technology Imagine a patient is in hospital during critical monitoring. ...
Cheap components from China: The underestimated risks in medical technology
Have you ever considered sourcing inexpensive components from China? The temptation is strong, we know that. And ...
Made in Germany: Why medical technology production is returning to Germany
In our globalized world, relocating the production of medical technology to the Far East seems attractive at first glance: Large ...
Manufacturing documents in medical technology
How to check your production documentation for audit readiness: Once production starts, it's too late for uncertainties in the documentation. ...
How AI replaces mediocre engineers – and makes good ones indispensable
The world of engineering is facing a profound transformation. Artificial intelligence (AI) is no longer a vision of the future – it is a reality. ...
Understanding Electrodermal Activity – Frequency Measurement & Applications in Medical Technology
May I introduce you? This is EDA – our owl for electrodermal activity. This is EDA, our little owl with a ...
Embedded Software: Everything has an end – Timeouts
In previous blog posts, I have presented two essential components of a simple and universally applicable software architecture: Events with Dispatchers, Listeners and ...
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