There really is no excuse for receiving a Form 483 observation for management review.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
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.