On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in

The EU Commission has issued a new guidance document for use with the EU 2017/745 MDR and EU 2017/746 IVDR.This

The Number of Notified Bodies is Increasing The EU Commission has authorized today the first notified body for the EU

MDCG 2019-10 Article 120 Guidance The guidance document for the implementation of Article 120, which many companies plan to use

EU Commission Factsheet for IVDR EU Commission issued a Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices. If you still