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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 β 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
A practical guide to conduct clinical investigations under the MDR
The implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical
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 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
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