Despite the enormous effort that most of us in the medical device industry have put forth in the development of internal audit procedures, it remains a difficult task due to the fact that we must audit our systems to ensure conformance to several different standards and regulations. This article focuses on guidelines and tools that can be used for audit- ing quality systems of medical device manufacturers.

First of all, you’ll need to determine what the level of conformance is for your quality system against Food and Drug Administration regulatory requirements. You should review the procedures and policies your company has developed, and determine whether they meet regulatory requirements before checking to see if they are being followed.

Despite the enormous effort that many in the medical device industry have put forth in the development of internal audit procedures, it remains a difficult task due to the fact that they must audit their systems to ensure conformance to several different standards and regulations.

Download the accompanying article, "GMP Auditing Techniques for Medical Device Manufacturers"