The system will allow healthcare professionals to reuse the critical care products up to 20 times during the COVID-19 pandemic.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
The agency has altered its import screening to accelerate the availability of PPEs.
The more devices are connected, the more that targets are present for remote attackers.
Diagnostic companies are hustling to increase availability of testing.
The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.
Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.
As the saying goes, if it looks too good to be true, it probably is.
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Both paper and digital paper are outdated approaches to medical device quality management.