Acknowledging that you need an effective QMS solution is the first step on the quality journey
Counterfeit goods may be the cheaper quality option, but they are not a substitute for the real thing
FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk
HBO's recent expose on the medical device industry flagged up some quality and compliance issues.
Websites and social media channels should be a consumer source for product recall and quality information.
Food safety should always be a priority for manufacturers, but an effective QMS process is a good place to start.
CAPA problems continue to bug medical device manufacturers as FDA inspections increase.
Summer is over, but product recalls are not affected by the changing of the seasons.
A weak link in the supply chain can have a significant impact on quality.
Regulatory compliance is both an essential part of the quality journey and a catalyst for product recalls.