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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
Drug or Device? Summary and analysis of MDCG 2022-05 on borderline products
Introduction In Europe, the commercialization of healthcare products is highly regulated. While medical devices are marketed according to EU
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),
IVD Clinical Performance Studies
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
List of Member States’ Competent Authorities for Medical Devices
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
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