Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.
Both paper and digital paper are outdated approaches to medical device quality management.
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.