Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
When it comes to adverse event reporting, the FDA does not grant exemptions.
Training is not a nice-to-have; it’s a fundamental requirement.
Failing to report serious patient injuries will win you a warning letter.
FDA expects all installation activities to be documented.
The medical device industry has more than its share of challenges, from regulations and changing business environments to the need to drive down costs and compete on price, all the while accelerating their ability to accelerate the process from order entry to order fulfillment.
If an activity is not documented, it did not happen.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
Documentation proves compliance, including when it comes to acceptance activities.
Don’t overlook this critical practice.