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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
What is good clinical practice (GCP)?
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
AUDITING A QMS ACCORDING TO ISO 13485
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
Clinical Performance Study applications for IVDs in Spain
In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of
Essential documents according to ISO 14155:2020
A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing
Roadmap to CE marking for medical devices and IVDs
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 for clinical investigations under the MDR
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
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
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