Comply all the time, not just when FDA announces an inspection.
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
You must have established procedures for complaint management and MDRs.
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
There is no such thing as minimum or maximum compliance—there is just compliance.
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.