Evalaution of the On Market Device to a Revised Standard

Q

QE

Hello All -

I am presently in the process of evaluation of a device that is on market to meet a standard as the regulatory associate wants this as an evidence to complete a EU submission for recertification.

The standards I am evaluating is ISO10555-1, ISO594-1, ISO594-2 and ISO11070.

Can some one from this group please provide me an example of a document that can help me perform this Gap Assessment in an easy and readable format.

Thank you
QE
 
Y

yodon

Leader
Super Moderator
I guess I'm a little confused about your question.

You have the standards, the standards define the requirements / expectations, you assess compliance against those requirements / expectations (to identify the gaps), and take whatever actions necessary to close the gaps. Can you be a bit more specific?
 
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Q

QE

Yes, what you said is exactly true. But the presentation of it is challenging. I was wondering if you can advise on a standard tool or a form to do so.

Thanks
QE

yodon said:
I guess I'm a little confused about your question.

You have the standards, the standards define the requirements / expectations, you assess compliance against those requirements / expectations (to identify the gaps), and take whatever actions necessary to close the gaps. Can you be a bit more specific?
Click to expand...
 
Y

yodon

Leader
Super Moderator
Ah, now I understand.

I don't know of any specific tools or forms. You might search the post attachments for "audit forms" or similar. Effectively, that's what you're doing. Basically, just a 3-column table: what the requirement is, what you're currently doing, and then your assessment of compliance.
 
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