Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,
Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
According to clinicaltrials.gov Europe is home to the second larges number of clinical trials. During the COVID-19 pandemic, the number of clinical
This article describes seven career paths available to people seeking to break into the field of clinical research. Clinical
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
The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing
D. Stern, Matthies, Julia Hagen, Brรถnneke, and F. Debatin depict the point of inflexion that the Digitale-Versorgung-Gesetz (DVG) will prospectively
Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes
Checkout our LinkedIn profile.
Checkout our selection of resources about medical devices and clinical writing.
AKRN Social Network