This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the ...

The EU Medical Device Regulation (MDR) has certainly caused significant impact to the medical device industry. Regulatory and quality professionals are still learning some of the nuances, and with the ...

Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a ...

Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) ...

LONDON--(BUSINESS WIRE)--Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR ...

LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...

Reprotech today announced that the TMRW Vault® has received CE marking as a Class IIa medical device under Regulation (EU) ...