Is it expected by the NB's that the current Declaration of Conformity (DoC) contain the GMDN code ... ?
Do NB's want the Declaration of Conformity with GMDN code?
- Thread starter somashekar
- Start date
S
SteveK
Re: Do NB's want the Declaration of conformity with GMDN code...
Not to my knowledge. However, I do reference GMDNs in the Product Dossier section of my Technical Files, even though I have never had a request from my NB to do so.
Steve
Not to my knowledge. However, I do reference GMDNs in the Product Dossier section of my Technical Files, even though I have never had a request from my NB to do so.
Steve
M
MIREGMGR
Re: Do NB's want the Declaration of conformity with GMDN code...
My Authorized Rep expects codes as part of our DoC.
Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)
My Authorized Rep expects codes as part of our DoC.
Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)
Do NB's want the Declaration of conformity with GMDN code...
Some NB's request manufacturers to add the GMDN code to the DoC and to the technical file.
It's not mandatory: never seen it neither in directive or in recommendations or meddev.
But I've never argued with NB auditors about that. If they want it, just pay the GMDN fee and add your code. An happy auditor is worth a few bucks.
Some NB's request manufacturers to add the GMDN code to the DoC and to the technical file.
It's not mandatory: never seen it neither in directive or in recommendations or meddev.
But I've never argued with NB auditors about that. If they want it, just pay the GMDN fee and add your code. An happy auditor is worth a few bucks.
W
wrodnigg
Re: Do NB's want the Declaration of conformity with GMDN code...
No, I do not require GMDN in any context.
(and I would request a different auditor, if one would require me spending money on that)
No, I do not require GMDN in any context.
(and I would request a different auditor, if one would require me spending money on that)
J0anne
Joanne
Re: Do NB's want the Declaration of conformity with GMDN code...
No Somashekar, it is not expected from any of the NBs I work with either.
http://elsmar.com/Forums/member.php?u=56337
No Somashekar, it is not expected from any of the NBs I work with either.
http://elsmar.com/Forums/member.php?u=56337
vinay anturkar
Registered
Re: Do NB's want the Declaration of conformity with GMDN code...
What is GMDN code?
What is GMDN code?
J0anne
Joanne
Re: Do NB's want the Declaration of conformity with GMDN code...
Vinay - Global Medical Device Nomenclature
Vinay - Global Medical Device Nomenclature
Re: Do NB's want the Declaration of conformity with GMDN code...
Your AR has no jurisdiction granted by regulation over the contents of your DoC. Did you grant them such powers via contract?
Your AR has no jurisdiction granted by regulation over the contents of your DoC. Did you grant them such powers via contract?
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