H
Hanson
Hi
Can anyone have idea about the additional requriements to normal ISO 13485 for CMDCAS audits? Thanks.
Can anyone have idea about the additional requriements to normal ISO 13485 for CMDCAS audits? Thanks.
Hanson said:Hi
Can anyone have idea about the additional requriements to normal ISO 13485 for CMDCAS audits? Thanks.
Your question is a little vague. Can you be more specific? What instructions? What requirement? The more specific, the better we will be able to provide information and answers.jonathan said:Can any body provide the instructions related to ISO 13485:2003 for CMDCAS audits?
The Guidance Documents you need are already posted in or linked to this thread.jonathan said:OK, thanks you both. My company have got the Certificate to sell products in Canada. Now we will update the quality system from ISO 13485:1996 to ISO 13485:2003. At the same time, we want to combine CMDR to our quality system. So I need some instructions, such as CMDCAS guidance, or the analysis list including the special requirements from CMDR.
Follow the link in post #3 to the Canadian Medical Devices web site. You will find the most recent guidance there.jonathan said:Yes, I saw a guidance linked. But that one was for ISO 13485:2003. I want to know whether the new guidance has been drafted or not. Or any other kinds of instructions can be useful?