The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
Going paperless is easier than you think.
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.