As a member of the Biomedical Division of ASQ, I received the following message.


Hi Biomedical Div. Members:
I am Bob, Chairman of the ASQ Biomedical Division Global Harmonization Task Force (GHTF) seeking input (constructive feedback) from your perspective. The input would be in the form of comments on current Proposed Documents from the GHTF Study Groups which are about to become final documents.
These guidance documents are intended to be used as a reference for both regulators and the medical device industry manufacturers. The guidance documents address a few areas of the medical device regulatory requirements. Please understand that the time of review and comment period is somewhat short. Comments must be provided prior to February 1, 2006.
This date will be here quickly. The comments must be provided per the template following the suggested format of the template. The template can be found at this address:
http://www.ghtf.org/shareddocs/Commentstemplate.doc (http://www.ghtf.org/shareddocs/Commentstemplate.doc)
The Purposed guidance documents cover a range of regulatory requirements. Therefore, if you wish to address only one guidance, please do so. If you wish to address more then one guidance documents, then please be my guest and address as many as you have time to complete.
The Proposed guidance documents can be found at www.ghtf.org (http://elsmar.com/Forums/www.ghtf.org) and on the upper right hand side of the web page there is an area with "GHTF Updates" which you can click on the SG of your choice and find the Proposed Documents. In addition, once you click on the SG, you will then find the document in PDF and WORD format as well as to whom to send your comments.
Or you can simply paste the address into your browser and attain the guidance document via that method.
These are the GHTF Guidance Documents which could be enhanced with your valuable input;
a) SG4(PD)/N30R16, Audit Strategy,
http://www.ghtf.org/sg4/inventorysg4/SG4(PD)N30R16.doc (http://www.ghtf.org/sg4/inventorysg4/SG4%28PD%29N30R16.doc)
b)SG1(PD)/N015, Medical Device Classification,
http://www.ghtf.org/sg1/inventorysg1/SG1(PD)N015.doc (http://www.ghtf.org/sg1/inventorysg1/SG1%28PD%29N015.doc)
c)SG1 (PD)/N040, Principles of Conformity Assessment,
http://www.ghtf.org/sg1/inventorysg1/SG1(PD)N040.doc (http://www.ghtf.org/sg1/inventorysg1/SG1%28PD%29N040.doc)
d)SG2(PD)/N54R6, Adverse Events,
http://www.ghtf.org/sg2/inventorysg2/SG2(PD)N54R6.doc (http://www.ghtf.org/sg2/inventorysg2/SG2%28PD%29N54R6.doc)
e)SG2(PD)/N57R6, Field Safety Notices,
http://www.ghtf.org/sg2/inventorysg2/SG2(PD)N57R6.doc (http://www.ghtf.org/sg2/inventorysg2/SG2%28PD%29N57R6.doc)
f)SG2(PD)/N79R5, Exchange Criteria & Report Form,
http://www.ghtf.org/sg2/inventorysg2/SG2(PD)N79R5.doc (http://www.ghtf.org/sg2/inventorysg2/SG2%28PD%29N79R5.doc)
Input from the Biomedical Members' expertise will benefit the Biomedical industry for both the regulator and the manufacturer. This cascades to a significant benefit to the medical device user and especially the patient. Thank you in advance for your efforts.

I believe that some people here might benefit from some of the draft documents available through the links and some should consider providing input about this harmonized processes. I am omitting the sender's information just to protect his privacy, but I am sure some other Covers who are also members of the BioMed Division should have received the same message.