IDCB 0129/0160 Clinical Risk Management

Sue789

Involved In Discussions
#1
As anybody have experience with DCB 0129/0160?
I am familiar with ISO 14971 and I have a Client who is working to DCB not sharing the documents they are generating I would like to include them in a Technical File. So what I am trying to ascertain is what is the difference between the current version of ISO 14971 and DCB 0129. A gap analysis would be wonderful.
Thank you in advance for your input
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
I don't see much (if any) daylight between 14971 and DCB 0129. There may be some elements of "compliant to 14971" systems as judged by 3rd-part European NBs that aren't specifically called out in DCB 0129... such as the infamous "reduce all risks as low as possible" paradigm... but otherwise I think the alignment is quite clean and obvious.

As DCB 0129 is specifically about IT systems, it is possible to encounter all sorts of confusion about topics like "assigning patient harm to exposure of protected health information" but that is a different topic.
 

Sue789

Involved In Discussions
#3
I don't see much (if any) daylight between 14971 and DCB 0129. There may be some elements of "compliant to 14971" systems as judged by 3rd-part European NBs that aren't specifically called out in DCB 0129... such as the infamous "reduce all risks as low as possible" paradigm... but otherwise I think the alignment is quite clean and obvious.

As DCB 0129 is specifically about IT systems, it is possible to encounter all sorts of confusion about topics like "assigning patient harm to exposure of protected health information" but that is a different topic.
Thank you very much for your input, I too could not see much difference hence the question. Was not sure if I was missing anything.
 
Top Bottom