Audits are the cornerstone of a QMS.
Fewer resources and more requirements are hindering the process.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
You need a management representative with oversight over medical device quality.
When launching a new product, manufacturers may want to consider Canada first.
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.