Using advanced technology still requires validation.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.
Every company should understand the value of employing statistics to assist in running a business.
Regardless, let’s look at stupidity in its highest form.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
You need a management representative with oversight over medical device quality.
Perhaps the organizational soul searching should begin after receiving one Form 483.
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.
Get an instant warning letter with repeat Form 483 observations.