A new report by trade association MedTech Europe has revealed that the struggle for manufacturers to meet the requirements of the EU’s Medical Device (MDR) and In Vitro Diagnostics Regulation ...

Tracey Technologies’ iTrace uses ray tracing technology to obtain precise measurements of the eye’s internal and external ...

“At a high level, new transparencies required under the Act relate to safety, which was already there in the EU’s Medical Device Regulation (MDR), and a more explicit focus on fairness.

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

ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced receipt of European ...

One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

Trace - True Ray Tracing Aberrometer and Topographer Tracey Technologies announced that the company has successfully achieved certificatio ...

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 ...

today announced receipt of European Medical Device Regulation (EU MDR) approval for the SmartFlow Neuro Cannula. The SmartFlow Cannula was previously cleared under the Medical Device Directive 93 ...

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