Recently, this practical guide has been published by the ISO Technical Committee that wrote ISO 13485:2016. This guide should be helpful for “cracking the code” of the 2016 standard, but there are few areas where it may cause confusion. … ISO 13485:2016 Practical Guide
Does your ISO 13485:2016 upgrade project need a power-boost? … ISO 13485:2016 Upgrade Power Tools for Sale
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations. … Clinical evaluation, investigation et al. in Europe MDR 2017/745
The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017. … Europe Clinical Evaluation Guidelines SmackDown
If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is WRONG. … Risk flowchart you won’t find in EN ISO 14971:2012
This should be one of the first questions asked during the medical device development process. … What standards apply to my medical device?
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated … EU MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req