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 that need to be...
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.
Nobody wants to work in an unsafe environment, but companies can often miss hazards that create preventable EHS incidents.
Creating a culture of quality in the workplace starts with reducing the potential for human error.
Companies need to send the right message to attract the next generation of quality professionals.
Employee training should be less of a necessary evil and more a path to continuous improvement.
Non-compliance with U.S. food safety standards could create a quality issue for importers.
Environmental compliance should be a priority for every company, but an EHS management system helps ...