Medical Devices in Canada: How to Enter the Market
When launching a new product, manufacturers may want to consider Canada first.
When launching a new product, manufacturers may want to consider Canada first.
Tag Archives: audits
EU Notified Body Unannounced Audits and Your Suppliers
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 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.
Preparing for Unannounced Audits
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 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?
FDA’s Single Audit Program Invites Participants
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.
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.
Management Review – Internal Audits are Not Rocket Science!
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.
Terms of Endearment
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.
Are you Ready for a Notified Body Unannounced Audit?
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.
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.
Surprise – We Are Here For an Unannounced Audit!
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.
Regardless of QMS Structure, Internal Audits are Mandatory
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.
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.
Not all Suppliers Need Audits
Why audit suppliers? We explain why some audits are necessary while most are not.
Why audit suppliers? We explain why some audits are necessary while most are not.
