Siemens Healthineers Changes Antibody Testing Conversation with New EUA
The Erlangen, Germany-based company has won the designation for semi-quantitative Sars-CoV-2 IgG antibody tests. The tests estimate the quantity of a patient’s antibodies produced against ...
READ MORE +Another COVID-19 Antibody Test Bites the Dust
FDA has revoked a previously-issued emergency use authorization for another COVID-19 antibody test.
READ MORE +Complying with ISO 14971:2019
Separate risk management and FMEA for better medical device development.
READ MORE +Strategies to Prevent Component Shortages During a Crisis
After years of economic expansion and a solid start to 2020, manufacturers found themselves suddenly, early in the year, in the middle of a global crisis with COVID-19. Its effects on manufacturing ...
READ MORE +Developing a Rapid Sars-Cov-2 Antibody Test
Research behind the test was published in the journal Vaccines on July 15, 2020.
READ MORE +Ensure Success Throughout the Entire Medical Device Lifecycle
Medical device experts advise focusing on quality at every stage.
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