The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key ...

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 ...

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, ...

The CE certification confirms compliance with regulatory standards for safety, efficacy, and quality management.

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 ...

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 ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft regulations reforming pre-market requirement for medical ...

New regulations in the European Union aimed at modernizing the regulatory framework for medical devices are imposing several new compliance obligations on all medical device makers that want to market ...

Evolus (EOLS) announced the EU Medical Device Regulation certification was received for four unique injectable hyaluronic acid gels under the brand name Estyme, branded as Evolysse in the U.S. market.

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 ...