They are standardized based on the size of the facility, what products you make and what activity is performed at the site. Thus, a large site of over 1000 people would have more audit days than one with 10. Similarly, if you make sterile devices you will have a every other year microbiology audit, which those who don't do sterilization will not. Additionally, under the MDD, all of your technical files must be audited on a rotating basis - usually every 3 years. Thus, if you have a lot of technical files, you will have more audit days compared to someone with fewer.
Most of the NBs have a copy of this matrix, but it is rather complex. I can see a situation where if you have a large site and a number of products, you would have a lot of audit days, even if sales are small. This could become even bigger if you are a supplier to other medical device companies, as you could get hit with additional "unannounced" audits as a supplier.
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
Original Message:
Sent: 23-Oct-2016 19:29
From: Hollie Johnson
Subject: Notified Body selection
Thank you for introducing this topic,
For a class IIa and IIb device, are the number and type of audits standardized? I believe that I am being over-audited by my NB (5 audits in 1 year) and am looking for something manageable for a water filter (dialysis and hospital water filtration). My sales are extremely low in EU. Any recommendations are helpful.
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Hollie Johnson
Director of Quality and Regulatory
Nephros, Inc.
River Edge, NJ
USA
hollie@nephros.com
732-403-4681
Original Message:
Sent: 22-Oct-2016 11:37
From: David Lim
Subject: Notified Body selection
Virginia,
If you have been working with a few NBs, you will find it good to work with Dekra.
Generally speaking, there have been some differences (minor to significant) how NBs enforce ERs.
Action to Take: Please talk to them and see how their process works (how responsive or how they handle disagreements, etc.)
Thank you.
s/ David
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Dr. David Lim, Ph.D., RAC, ASQ-CQA