The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. This short course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects.
Take this course here: http://bit.ly/2u6aaHv
Semoegy provides in training courses specialising in medical technology. We also provide information resources and best practices in easy-to-understand formats. You can already find some regulatory infographics on our website.
Verification - confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.