TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end
Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,
Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a
Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD
By the end of 2021, the European Parliament adopted the proposal of the European Commission to amend the EU 2017/746 in vitro diagnostic medical
Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
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