We are a US mfg. of medical calibration gases and I am in the process of preparing our technical file to comply with the MDD. We are also in the middle of completing our ISO 13485 certification. Is there a side by side comparison between the requirements of 21 CFR 820 to ISO 13485? I have seen such a comparison to ISO 9001.

There is one that I've seen posted here at the forums in the past that was prepared to when the current version of ISO 13485 was still in draft. I'm attaching a version of that comparison which I've recently extensively modified and updated. I hope it helps!

We are a US mfg. of medical calibration gases and I am in the process of preparing our technical file to comply with the MDD. We are also in the middle of completing our ISO 13485 certification. Is there a side by side comparison between the requirements of 21 CFR 820 to ISO 13485? I have seen such a comparison to ISO 9001.

Hello Ray, Welcome to The Cove Forums! :bigwave: :bigwave:

I did an advanced search on: "21 CFR 820 to ISO 13485 (http://www.google.com/custom?domains=Elsmar.com&q=21+CFR+820+to+ISO+13485%3F&sa=Search&sitesearch=Elsmar.com&client=pub-1385417534940691&forid=1&channel=6124086287&ie=ISO-8859-1&oe=ISO-8859-1&cof=GALT%3A%23008000%3BGL%3A1%3BDIV%3A%23336699%3BVLC%3A663399%3BAH%3Acenter%3BBGC%3AFFFFFF%3BLBGC%3A000099%3BALC%3A000000%3BLC%3A000000%3BT%3A0000FF%3BGFNT%3A0000FF%3BGIMP%3A0000FF%3BLH%3A50%3BLW%3A350%3BL%3Ahttp%3A%2F%2Felsmar.com%2Fpng%2Fheader-G-search.png%3BS%3Ahttp%3A%2F%2FElsmar.com%2FForums%2F%3BFORID%3A1%3B&hl=en)."

There may be some links to posts that are useful to you.

Stijloor.

I have changed the title of this thread to better clarify your request.

There is one that I've seen posted here at the forums in the past that was prepared to when the current version of ISO 13485 was still in draft. I'm attaching a version of that comparison which I've recently extensively modified and updated. I hope it helps!
Thanks for your help, this project seems a bit daunting.

Thanks for your help. I am new at this web site and I hope to be able to find help in getting this technical file completed. We are CE registered but have issues that need to be clarified.:agree1:

We are a US mfg. of medical calibration gases and I am in the process of preparing our technical file to comply with the MDD. We are also in the middle of completing our ISO 13485 certification. Is there a side by side comparison between the requirements of 21 CFR 820 to ISO 13485? I have seen such a comparison to ISO 9001.

There are lot of similarities and if you comply with ISO 13485, you would be very close to 21 CFR Part 820. :)

Thanks for the information.

There is one that I've seen posted here at the forums in the past that was prepared to when the current version of ISO 13485 was still in draft. I'm attaching a version of that comparison which I've recently extensively modified and updated. I hope it helps!
This is going to be incredibly helpful to me. Thank you so much for taking the time to do this (and post it!)

Hi


Would it be possible to send me/post the file in its native format please - word or excel. I am doing a gap analysis against all our internal procedures and it would help tremendously


Regards

Graham

Hi


Would it be possible to send me/post the file in its native format please - word or excel. I am doing a gap analysis against all our internal procedures and it would help tremendously


Regards

Graham

Hi Graham, welcome to the Cove. :bigwave:

Here's the file in Word format.

Dear Howste,


Thank you very much for this - it will save me a great deal of time.

If you ever need anything from me, I am an eng mgr at an orthopaedic company in the UK (EU)

Thanks again

Regards

Graham

Howste,
Your checklist comparison is a great help-aid. I appreciate the time / effort you put in to make "my" job easier.

Thanks,
Betty

There is one that I've seen posted here at the forums in the past that was prepared to when the current version of ISO 13485 was still in draft. I'm attaching a version of that comparison which I've recently extensively modified and updated. I hope it helps!
howste, Can u please update a doc file? thanks, in advance.

howste, Can u please update a doc file? thanks, in advance.

The doc file (MS Word) is attached in post 11 above...