Top menu

Archive | November, 2011

News for ISO 10993-1:Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

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 […]

Continue Reading 0

Risk management conference

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 […]

Continue Reading 0