Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Comply all the time, not just when FDA announces an inspection.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.
The underlying purpose of the Medical Device Single Audit Program is to allow one of five regulatory bodies to perform an inspection and then share the results with the other agencies so additional/duplicate inspections are not required.
Inspection, measuring, and test equipment form a significant part of the quality-system foundation for successful medical device manufacturers. Device manufacturers need effective tools to gage adherence to approved product specifications; and the vehicle employed for doing so is the performance of acceptance activities utilizing inspection, measuring, and test equipment.