Re: Does a 14971 guidance document exist?
The only standard for application of ISO 14971 is in relation to application to software.
IEC/TR 80002-1 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
However, there´s a publication by CSA which has what you need:
PLUS 14971 - The ISO 14971:2007 Essentials - A Practical Handbook for Implementing the ISO 14971 Standard for Medical Devices
***DEAD LINK REMOVED*** See Post 7 in this thread for current link.
Update: please note that correctly implementing ISO 14971 is a little difficult and even this CSA book won´t have all the answers, but it will surely shed some light on the process.