FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
QMS Implementation for Class I Devices Under EU MDR
OVERVIEW The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone […]