Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a better understanding of the new EN version of ISO 14971 - EN ISO 14971:2012, and learn how to implement it into their daily risk management activities.
[fa icon="clock-o"] 7/26/13 5:09 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] standards, iso 14971, risk management, Standards Compliance
Read More »In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide evidence of compliance.
[fa icon="clock-o"] 3/5/13 6:11 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] standards, european commission, IEEE, MDD, Medical Devices, BSI, medical device field, medical device manufacturer, country code, FDA, ASTM, RTCA
Read More »You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
[fa icon="clock-o"] 2/7/13 9:25 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] standards, MDD, iso 14971, medical device, Medical Device Directive, ISO, iso 13485
Read More »
