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Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.
My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.
I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.
Thanks, Look forward to hearing from you all.
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.
My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.
I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.
Thanks, Look forward to hearing from you all.
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However the FDA/MDD/CMDR/Australia Regs Excel spreadsheet does go a long way to help understand the differences.