In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
5/31/2022
/ Certifications ,
Classification ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EFTA ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Software
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more
4/12/2021
/ Coronavirus/COVID-19 ,
Data Transfers ,
EU ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Medical Directives ,
Popular ,
Software
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more
As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of...more