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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
The quality management system according to ISO 13485
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall βestablish, document,
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),
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
Impact of MDCG 2021-21 on SARS-CoV-2 IVDs
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
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
What is CE marking and do all products need CE marking?
Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under
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