I virtually never use the word "fault" except when discussing earthquakes. It is a given that no one (including perhaps Anon and perhaps the AO) knows why the certificate has yet to be issued. However, I've been around enough blocks to know that when a service provider hasn't delivered for over three months, and does so two weeks after being "nudged," it's a virtual guarantee that something went amiss on the service provider's side of things. Or that they are so out of control, their "deadline" is "within a couple of weeks of the client finally complaining."
Regardless of promises made, implied, expected, or even imagined, failure to keep customers informed is simply dismal customer service. In a similar situation long ago, my department defined "service failure" as not having delivered on deadline and "catastrophic service failure" as having neither delivered nor contacted the client. I still observe those definitions.
I'm not clear on the inability to shop for good customer service, unless you are saying there is none to be found among all the AOs, NBs, and Regulatory Agencies out there. Certainly there is no option for comparison shopping among NBs in the EU right now, but otherwise, companies have always shopped for AOs and NBs, although often with somewhat different criteria for "good" customer service than good communication, heh. Companies have also always shopped for regulatory agencies, when selecting which markets to enter and sites for the conduct clinical trials, and one of RA's most important roles has always been to inform this shopping.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 12-Dec-2019 18:50
From: Ginger Cantor
Subject: notified body performance
My only wish is that AOs would staff in even their certificates group, to notify customers proactively on what is happening - where the hold up is, rather than making the customer guess.
We don't know in this case all the transactions between the two, but man if something is that late and you have verbally or otherwise told the client to expect a certificate in 30-60 days.... then proactively call the client and say "I am so sorry to tell you it is delayed at the reviewing board". and then followup.
But AOs, NBs and Regulatory Agencies have all the leverage, so that is not a likely scenario. Manufacturers do not have the luxury to shop for good customer service. Qualified experts, yes, but often lacking in customer service.
(Sigh)
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 12-Dec-2019 17:18
From: Brittany Gibson
Subject: notified body performance
Hi Anonymous,
That's quite a long time to wait. It took about 140 days to receive mine last year. Have you inquired with your auditing organization about the wait? In my situation I contacted my auditing organization, who then had someone from their certificates department look into it. They informed me that their MDSAP panel was still reviewing the report, and promised an expedited review once their review was finished. Once I had nudged them about it, I received the MDSAP certificate in 2 weeks.
I agree with Mark - there's a process behind all of this that may not make it the AO's fault for some delays. In addition to the contacts posted in a previous response, Neil Mafnas is the FDA's MDSAP program coordinator (neil.mafnas@fda.hhs.gov), but I would recommend trying to expedite this through the AO first.
Best of luck,
Brittany
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
Original Message:
Sent: 10-Dec-2019 16:02
From: Anonymous Member
Subject: notified body performance
This message was posted by a user wishing to remain anonymous
It's been 287 days since my MDSAP audit and I still don't have the certificate. Is there a higher authority where I can file a complaint?