Denying the agency to inspect your facility is a violation.
The shoulder replacement is used on patients with rotator cuff tears.
Part III of the series on remediation looks at how companies can tie risk priorities into the remediation process.
Selling expired devices? Oh, no.
Is your risk management process fully operational right now?
Furry critters have no place in a medical device manufacturing facility.
The technology helps doctors find the origin of an irregular heart rhythm.
Human factors addresses not only the obvious or physical, but also digs deep.
Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.
How you respond to Form 483 observations matters.