How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Think outside of the box and approach your QMS with passion and creativity.
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?