You perhaps believe that you can read which requirements apply in the laws and standards for medical device manufacturers like ISO 13485 or 93/42/EEC, and to an extent that’s true. But to an increasing extent I’m encountering requirements that notified bodies and authorities have set and which aren’t documented anywhere. These requirements are much more […]
Reflections and stories from life in the medical device industry.
Automating risk evaluation Using MS Excel as a typewriting tool does work, but by implementing a few hacks, you can get so much more out of it, and most importantly, you can save time. In this video I will show you how to automate the risk evaluation process. Conditional formatting for risk evaluation cells Another […]
Nice to be acknowledged by press for creating new products in the medical device field!
The five day meeting on the second edition of the IEC 62366 standard is nearing its end. It has been a long week; interesting but long. I am of the general opinion that meeting usually never have to be more than 60 minutes. At least not when there are 14 people in the room. We […]
ISO 10993:2009 Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process has a secondary objective of avoiding redundant in-vivo tests. But even if that is true for Europe, important markets such as US and China still require that all the tests are done, so the question is whether the possibility […]
The risk management conference participants discussed FMEA in relation to ISO 14971 and risk analysis. The conclusion was that FMEA is not risk management, nor risk analysis. Not so revolutionising, but still creates discussions. On the two-day risk management conference in Berlin, representatives from industry and notified bodies met to discuss risk management. Presentations were […]
On Wednesday, I was booked for two practice sessions for my pitch. The idea is that you should present the company in 4 minutes. Four minutes is an incredibly short time! Apparently I did something right, because on Thursday Vivoline Medical AB won the contest MedTech Investment Day Award. But it was of course not […]