The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.
Not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.
Unannounced notified body audits are nothing new. Unfortunately, because of one really bad apple in the industry and a perception of the regulatory environment in the EU lacking teeth, the Commission has come up with an unrealistic and expensive solution for industry.
Not all auditing firms or auditors are created equal; in fact, there is “The Good, The Bad, and The Ugly” when it comes to auditors.
Why audit suppliers? We explain why some audits are necessary while most are not.
The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…