The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks.

That’s why, when Greenlight Guru released its “State of Medical Device Product Development and Quality Management Report,” readers were surprised to discover most medical device companies wouldn’t be prepared in the event of an unannounced audit.

In particular, we found that one of the most striking dividing lines between the prepared and unprepared was the use of best-in class-tools. Our research found that 40 percent of companies that invest in quality tools say they’re very confident they could pass a surprise audit; fewer than 20 percent of companies using legacy tools feel the same.

Here, we’ll explore possible ramifications of being caught unprepared for unannounced audits and inspections, and the actionable steps quality managers can take not only to survive these harrowing events but also thrive when it matters most.

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