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
What are the requirements for a clinical evaluation for legacy and well-established technology devices?
Following the publication of the MEDDEV 2.7-1 in 2016 rev 4 and subsequently Medical Device Regulation 2017/745 (MDR), medical device manufacturers
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing,