Cybersecurity is no longer seen as an option in medical technology; it's mandatory. With IEC 81001-5-1 and the requirements of the MDR, manufacturers of medical devices and health software must systematically identify, assess, and mitigate security risks. ...
Modeling mechanical architecture
How do you create an architecture for a mechanical specification? I want to answer this question in this blog post. A system consists of ...
Requirements Engineering with Enterprise Architect
This blog post is intended to help everyone who still creates requirements specifications with Word and Excel. I myself also used them for a long time. ...
ISO 13485 – What does it actually say?
Anyone working in the medical technology sector has probably heard of the ISO 13485 standard. It deals with quality management systems for ...
Book tip: Medical Instrument Design and Development
Recently, a reader of the blog and good colleague recommended a book to me that, in my opinion, is particularly... ...
Systems in medical technology – setting sensible limits
What is a system? What initially sounds like a simple question can sometimes be quite complex. Because the question ...
Do you speak SysML?
Even today, document-centric workflows are widespread in development. But is this approach still up-to-date? Or ...
Call for Blogs – Guest Bloggers Wanted
Do you have expertise in medical technology and are you an absolute expert in your field? Then share your knowledge! ...
Guest lecture at the OTH Amberg-Weiden
Last Monday (June 1st, 2015) I had the opportunity to give a guest lecture on my favorite topic, Systems Engineering, at the Ostbayerische Technische Hochschule in Weiden. ...
Polarion in medical technology
The development of medical technology products places high demands on documentation and traceability. This is especially true in the development of ...
Introducing system architects into the company
More and more companies in the medical technology sector are recognizing the value of system architects. And this trend will continue to grow in the future. ...
System architects – why we need them and what they should be able to do?
More and more companies in the medical technology sector are recognizing the value of system architects. And this trend will continue to grow in the future. ...
MDD, MPG and Co.
Anyone working in medical technology should also be familiar with the necessary laws and regulations. Therefore, today I would like to... ...
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