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Help!!!
Howdy everyone.
I have just found out that we will be pursuing certification to ISO 13485 (actually 13488). Can anyone recommend any good resources for information so I can get up to speed on this standard. I have a very good understanding of 9001:2000 (which I've heard is similar), but know nothing about the medical side of things. I need to find out what the major differences are, and what extra steps need to be taken (we are certified to 9001:2000). Thank you in advance for all your help.
Howdy everyone.
I have just found out that we will be pursuing certification to ISO 13485 (actually 13488). Can anyone recommend any good resources for information so I can get up to speed on this standard. I have a very good understanding of 9001:2000 (which I've heard is similar), but know nothing about the medical side of things. I need to find out what the major differences are, and what extra steps need to be taken (we are certified to 9001:2000). Thank you in advance for all your help.
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