Procedures for design validation must address risk analysis where appropriate.
When it comes to adverse event reporting, the FDA does not grant exemptions.
In pursuit of the almighty dollar, this case involves the smuggling of lamb fat.
When FDA says stop, they mean stop!
All equipment must be qualified and calibrated for its intended use.
Can your company prove its device has been manufactured in accordance with its DMR?
Managing suppliers is critical, and your processes in doing so must be documented.
APRIL FOOL’S! FDA inspectors don’t want to discover hungry rodents enjoying a meal of device history records.
Failure to comply with FDA’s wishes landed three companies warning letters.
Audits are the cornerstone of a QMS.