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.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
By simply scanning a barcode, SoomSafety gives users access to important product instructions, safety and recall information.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
Conducting usability tests will help manufacturers reduce the risk of harmful use errors and enhance device effectiveness.
Well-written and usable instructions are critical for all users.