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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
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,
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 as your Contract Research Organization (CRO) in Italy, Spain and Portugal
According to clinicaltrials.gov Europe is home to the second larges number of clinical trials. During the COVID-19 pandemic, the number of clinical
Seven entry points into clinical research
This article describes seven career paths available to people seeking to break into the field of clinical research. Clinical
Conducting clinical investigations successfully
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
What You Need to Know About the New ISO 14155:2020 Standard
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
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