Essential Requirements checklist as per unrevised MDD (MDD 93/42/EEC)

Hi

Would anyone have an ER checklist as per the unrevised MDD 93/42/EEC. It appears that the one that I have is as per the new revised directives and that happens to be unacceptable to our auditors. Would appreciate all help in this regard.

Priya

Re: Essential Requirements checklist as per unrevised MDD

Here is a template we used to use before the revision. Apart from this, I find it strange the auditors don't accept a new list.

Re: Essential Requirements checklist as per unrevised MDD

We have the same version of ER checklist as you "LievenDW" posted here. But, there is a newer one, issued after the amends from 2010-03-21. This date is the important one as for searching on the net.

Snovit

Re: Essential Requirements checklist as per unrevised MDD

Thanks to you Belgium...my night has just gotten shorter.

Re: Essential Requirements checklist as per unrevised MDD

Snovit said:

We have the same version of ER checklist as you "LievenDW" posted here. But, there is a newer one, issued after the amends from 2010-03-21. This date is the important one as for searching on the net.

Snovit

Click to expand...

Hello,

Would you mind posting the most recent checklist?

Thanks,

San Jose 95125

Re: Essential Requirements checklist as per unrevised MDD

Here is a copy of my recent checklist. Please beware that in our company we only have class I and IIb devices, so that not all annexes apply to us.

Lieven,

Thank you for posting this checklist. It is very helpful.

Please let me know if I may be of any assistance. You may contact me thru LinkedIn.

Best regards,

Garth Nobis (device RA/QA expertise)

Re: Essential Requirements checklist as per unrevised MDD

Hi Lieven

I am looking for a template technical agreement for a class III medical device.

Do you know where I can find this eventually ?

thanks
kr

Isa