“Your most unhappy customers are your greatest source of learning” – Bill Gates
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.
Summer is over, but product recalls are not affected by the changing of the seasons.
The auto industry is always touting the continuous improvement in the driving experience, but missing parts can be a problem.
Frogs, fish, fire and the daily work of the FDA ... just some of the QMS topics that surfaced in July.
Quality is under pressure every day. Our new monthly round-up provides a few highlights.
Complex hardware plus short product lifecycles equals quality management problems.
Product recalls are never welcome, but quality wins when the recall is done right.