The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Validation is an obstacle to implementing technology. A streamlined approach is necessary.
The agency has issued its list of the most common inspectional observations for FY 2017.
Using advanced technology still requires validation.
An important yet often mysterious part of validation.
How to prepare for a successful transition.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.