Articles – Resources – AKRN Social network
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
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
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
How to set up agreements to conduct a clinical investigation?
Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,
How to conduct a clinical investigation of medical devices in Portugal
Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and
AKRN Social Network