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Artificial Intelligence challenges in Medical Devices
Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used
ÅKRN IS NOW ISO 9001 QUALITY CERTIFIED
Madrid, 24th August 2022 - We are pleased to announce that AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized
DEVELOP AND IMPLEMENT YOUR QMS ACCORDING TO ISO 13485
Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the
AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)
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
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
Progressive roll-out of the IVDR: extended timelines for certain IVDs
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
CER according to the MDR
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
What is a Medical Device?
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
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