The agency has altered its import screening to accelerate the availability of PPEs.
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.
From artificial intelligence to autonomous sterilization robots to drones, emerging technologies are playing a strong role in combating COVID-19.
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Both paper and digital paper are outdated approaches to medical device quality management.
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
The self-driving UV disinfection robots are being sent to more than 2000 hospitals.