 |
| Sometimes it’s your company that forces a new direction during the inspection, sometimes it the auditor. Sometimes it’s both. |
Adventures of a seasoned inspector. Really, what could go wrong?
By Morris Sherwood
Director, Regulatory Affairs and Quality Assurance
Isolite Systems
So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.
READ MORE »