• 11/12/2025
  • Security

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 ...

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What IEC 81001-5-1 means for medical device developers
  • 09/12/2025
  • Systems Engineering, Company

SysML v2 is thus revolutionizing the development of surgical lights in medical technology.

Variety of variants and pressure to integrate: The invisible bottleneck in operating room lights. Operating room lights may seem inconspicuous at first glance, but they are technologically highly complex medical devices. ...

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SysML v2 is thus revolutionizing the development of surgical lights in medical technology.
  • 01/12/2025
  • General, Hardware, Standards, Requirements Engineering

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 ...

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EMC for medical devices: Why IEC 60601-1-2 alone is not sufficient
  • 26/11/2025
  • General, Hardware, Standards, Quality, Testing

What does EMC mean for medical devices in practice?

Why EMC testing is vital in medical technology. Imagine a patient is lying in the hospital during critical monitoring. Suddenly ...

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What does EMC mean for medical devices in practice?
  • 20/11/2025
  • General, Hardware, Quality, Technology, Testing

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 ...

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Cheap components from China: The underestimated risks in medical technology
  • 13/11/2025
  • General, manufacturing, production, quality, company

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 ...

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Made in Germany: Why medical technology production is returning to Germany
  • 04/11/2025
  • Manufacturing, production, quality

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. A missing document... ...

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Manufacturing documents in medical technology
  • 29/10/2025
  • General, Quality, Company

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. ...

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How AI replaces mediocre engineers – and makes good ones indispensable
  • 25/09/2025
  • General, Electrodermal Activity, Hardware, Production

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 special ...

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Understanding Electrodermal Activity – Frequency Measurement & Applications in Medical Technology
  • 09/09/2025
  • General, Software

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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Embedded Software: Everything has an end – Timeouts
  • 30/07/2025
  • Production, company

Medical Device Manufacturing: Why Teamwork and Expert Knowledge Make the Difference

How does the manufacturing of medical devices work? When you think of manufacturing, you often have images in your head of machines that ...

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Medical Device Manufacturing: Why Teamwork and Expert Knowledge Make the Difference
  • 19/03/2025
  • General, Companies, Events

Invitation VDI Event 28 March: SysML v2 – With Tim Weilkiens

We are pleased to invite you to an exclusive VDI Network Systems Engineering event, which will take place in our office!On Friday, ...

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Invitation VDI Event 28 March: SysML v2 – With Tim Weilkiens