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... ...
Do you enjoy circuit technology?
If you enjoy working with an oscilloscope, are familiar with transistors, and want to develop electronic circuits, then come join us! ...
Annex A11:2021 of EN ISO 13485:2016
If you are also active in medical technology, then you have probably already heard that EN ISO 13485:2016 is a ...
Already have plans for next year? Come to MEDtech!
Got plans for next year? We're looking for software developers for embedded systems in medical technology. If you ...
Harmonising usability and systems engineering
Systems engineering deals with the development of a high-quality overall product. Usability engineering, on the other hand, aims to provide the user with a ...
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 ...
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