Medical Device Auditor - Training and other Requirements

M

maypan

#1
Dear All,
How do you train to be a medical device auditor. What are the topics that you need to know and master? Assume that you already know most of 510K process, all ISO 13485, 9001 and 14971. How do you put these all in prespective and do the auditing job in a stepwise fashion?
Otherwise, what steps or specific knowledge makes your life easier?
Thanks
 
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sagai

Quite Involved in Discussions
#2
Re: Medical Device Auditor

Hi Maypan,
it very much depends on the scope of the auditor work.
For internal auditor, ISO13485, ISO9001 is almost more than the ones known by internal auditors.
For customer audit, ISO13485 and QSR are mostly satisfactory.
For third party audit ISO13485 and ISO14971 + the device related standards are the ones I would consider to master.
And not for last, for FDA inspection, I think there could be info on their website.

br
Sz.
 

RA Guy

Involved In Discussions
#3
Re: Medical Device Auditor

This is useful for learning the FDA inspection approach:
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm

I tend to use harmonized checklists that incorporate all external requirements (e.g., ISO, FDA, MDD, etc.)

As far as progressing to the level of a lead auditor, the high level steps are as follows:
- learn the source material (QMS standards, regulations, etc.)
- Learn the auditing process (planning, conducting, reporting, etc.)
- participate in audits starting at a low level (observer) and move up as you get more experienced to team auditor and then lead auditor.

If you are new to auditing and the standards and regulations, I strongly recommend taking formal training and/or getting experience in your current company (volunteer to join the internal audit team).

The 510(k) process is not the most relevant knowledge for an medical device auditor. You would need to study the application of 21CFRPart 820, also known as the Quality System Regulations that can be found on the CDRH website.
 
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