The Documentation of Data Analysis for an ISO 13485 Medical Device Submission

G

Ginnie

Good afternoon all,

We are gathering all our data for a kit we are submitting for a ISO 13485 medical device submission. My question is: How should the data be displayed? Example: In book form: chapter 1, etc; or a PDF file or just a summary with tables and attachments for the raw data.

I would appriciate any help that any one can give me.

Ginnie
 

rob73

looking for answers
Ginnie
I what context do you mean "We are gathering all our data for a kit we are submitting for a ISO 13485 medical device submission."? ISO 13485 is a quality management system and devices are not generally submitted against this standard, for instance in the EU it would be the medical devices directive that compliance would be subitted to. Is this data for a technical file for FDA or CE approval? Could you please clarify your intent.

Rob
 

pkost

Trusted Information Resource
However it is best to convey!

I would suggest contacting your notified body (or body you are submitting to) and asking them. I would hazard a guess that they would want a summary of the data

what you collected
How you collected it
why you collected it
How you analysed it
why you analysed the data that way
Summary of results
Conclusions drawn

I doubt they would care too much about the 250 questionairres you sent out, or the electronic data collection which was sampled at 1000Hz for 24hours.
 
G

Ginnie

In order to apply for ISO 13485 you must have a IVD product to submitt. We are also applying for CE mark. I'm just not sure how to arrange the raw data along the necessary information. I have an example from the FDA but I'm sure that we don't need all the informtion that is required for them. I'm really new at this position and don't want to fail at the most important part of my job.

Thanks for your help.

Kathy
 

pkost

Trusted Information Resource
There is no need to have a product to apply for ISO 13485. ISO 13485 defines the requirements for a quality management system with specific application to medical devices.

I can't advise for the FDA. For CE marking of an IVDD my comments above still stand - I would advise speaking to your notified body and asking what they would like to see!

You should organise the data so that it is easily retrievable

put yourself in the position of the auditor/reviewer...They will be asking themselves if the tests are valid and the data sufficient to support the conclusion. Lay out the information in such a way to make this as easy as possible for them
 
G

Ginnie

Thanks, so much. I'm just a bit nervious about the up coming inspection.

Have a great day!!!

Ginnie
 
G

Ginnie

Hi everyone,

I'm back with more questions. The auditor said that our audit procedure is too vague, it is only 2 pages. I'm to rewrite the procedure and I'm not sure where to begin or where I can find examples. I would greatly appreciate any information that I can obtain.

With much graditude for finding this web site.

Ginnie :bigwave:
 
S

SteveK

Hi everyone,

I'm back with more questions. The auditor said that our audit procedure is too vague, it is only 2 pages. I'm to rewrite the procedure and I'm not sure where to begin or where I can find examples. I would greatly appreciate any information that I can obtain.

With much graditude for finding this web site.

Ginnie :bigwave:

Hi Ginnie,

My Internal Audit SOP is only 3 pages (of text) and I've not had any issues with our NB. I've attached a copy (it obviously references other 'Acme' documents).

I hope this helps.

Steve
 

Attachments

  • Internal Audit SOP.pdf
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G

Ginnie

Thanks so much. I'm so happy to have found this web site. It is such a competitive and fast paced world you cannot find any mentors to help a new bee.
Again much appreciation,
Ginnie
 
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