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List of Global Medical Device Nomenclature (GMDN) Codes Brief Summary: The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term 01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro-mechanical devices 05 Hospital hardware 06 In vitro diagnostic devices 07 Non-active implantable devices 08 Ophthalmic and optical devices 09 Reusable instruments 10 Single use devices 11
Where to get GMDN Codes - The Elsmar Cove Quality Forum My company sells orthodontic products worldwide Recently a Malaysian customer needs these I think it's just the latest scam but I'm curious How are these used? Does a doctor or health agency have to pay the membership fee to actually Make Use of these generic descriptions of medical devices? Is this all because of the worldwide problem of bad language translation? Thanks for any insight
List of Global Medical Device Nomenclature (GMDN) Codes Attached is a excel file that has a list of GMDN codes It was translated using google's translator tool box I can't verify the date that the GMDN list was compiled or the accuracy of google translate but it is a good place to start Source file was found from the link below (broken link removed) It seems very apropos to say: It's all Greek to me
GMDN (Global Medical Device Nomenclature) Codes Hi I have been asked for the GMDN codes for our products as part of product registration Is there any way to access the codes without having to be a member of the GMDM, which costs €1500 + €1000 per year? For IVDs, I can find a cross reference between EDMA and GMDN which lists all IVD
ISO 14971 Clause 9 Requirements - Post-Production Monitoring and Risk . . . In ISO 14971:2009 clause 9 talks about post-production information and review and update of the risk management file I am looking for ideas thoughts on how people meet this requirement Do you yearly review each product and then create a report that gets added to the risk management file
Evaluation of Uncertainty of In Vitro Diagnostic Kit Calibrators Dear all, I am a guy in the in vitro diagnostic medical device industry As ISO 17511 requires, an uncertainty should accompany any calibrator enclosed in the in vitro diagnostic kit In my company's product, the value of the calibrator is obtained from 4 parameter data reduction method and