The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
COVID-19 requires us to rethink our current device disinfection procedure.
Diagnostic companies are hustling to increase availability of testing.
Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.
The adoption of accurate non-invasive measures of liver health at the point of care is critical.
There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
This new pathway is a considerable change for the medical device industry.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.