Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
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.