Hi Mike,
I had this experience some years back and that inspection was an EPRC inspection only, not a combined regular and EPRC. I guess this will be the same for you, since the company had the MDSAP Audit.
The key take home from that experience was that this EPRC inspection was in no way supplementary to a medical device quality system inspection. It was all based purely on the EPRC regulation.
Regarding what to expect, the EPRC Program home page is a good start and does lead to all relevant requirements and to their expectations. You may expect them looking at your product portfolio, identifying the type of EPRC product and the corresponding
performance standards. You should take a fresh look at the products and not simply start with the product codes as given by your device listings, 510(k)s. This will define the scope for the inspection.
Next is to look if you meet the performance standards, labeling requirements as well as reporting requirements (product reports, annual reports).
Regarding MDR, complaints and CAPAs, it is worth noting that what is considered an 'accidental radiation occurrence' (ARO) may not be identical to what you consider to be an MDR.
Good Luck
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Alexander Schwiersch
München
Germany
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Original Message:
Sent: 27-Jul-2019 16:52
From: Mike Loiterman
Subject: FDA EPRC Inspection
Has anyone been through an International EPRC inspection by FDA? My parent company, based on Germany, will undergo this kind of inspection by FDA in September. Interestingly, they've already completed their MDSAP Audit.
Apart from the following page, I haven't been able to find much about the requirements and what to expect:
https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program
I assume scope will be for product codes listed here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
Are they then looking at, with respect to product codes listed above, Design History Files, Annual Reporting, MDR, Complaints, CAPAs…all of the above, something else?
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Mike Loiterman
Cell: 630-302-4944
Email: mike@ascendency.net