Top 5 Pitfalls You Should Know About Medical Device Quality System Auditing

By Ava Anderegg

Although many medical device firms fail to comply with medical device audit regulations or assume an adversarial position, there are benefits to consistent, targeted audits as well as the collaborative intentions of inspectors themselves. There are a few critical questions that should be asked while planning medical device audit management activities, and these questions will help you to consistently be prepared for audits. 

Investigators have also identified a list of five common problem areas with medical device quality system auditing. Familiarity with these problem areas can reveal key quality indicators on which to focus, also allowing you to be audit-ready on a daily basis. Taking these problem areas into account will help to create an auditing solution that handles systemic problems.