TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end
Introduction In Europe, the commercialization of healthcare products is highly regulated. While medical devices are marketed according to EU
Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the
The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Medical Device Regulation (EU) 2017/746 (hereinafter referred to as MDR and
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
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
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
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