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Results For "Medical-Device-Regulation"

6 News Found

Glaukos receives EU MDR certification for iStent infinite
Medical Device | July 02, 2025

Glaukos receives EU MDR certification for iStent infinite

The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma


Poly Medicure receives MDR certification for 54 products
News | March 12, 2025

Poly Medicure receives MDR certification for 54 products

The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


Henkel joins MedTech Europe to drive innovation in the medical technology industry
News | September 20, 2023

Henkel joins MedTech Europe to drive innovation in the medical technology industry

Reinforces Henkel commitment to supporting customers and ecosystem in medical healthcare


Biocorp and HRA Pharma to jointly develop a medical device innovation
Medical Device | March 16, 2023

Biocorp and HRA Pharma to jointly develop a medical device innovation

Biocorp will receive an initial milestone payment this year


Merck awarded €121 million contract for flow membrane production facility in Wisconsin, USA
Clinical Trials | December 30, 2021

Merck awarded €121 million contract for flow membrane production facility in Wisconsin, USA

The contract award from the U.S. Department of Defense (DoD), on behalf of the U.S. Department of Health and Human Services, is part of an effort to ensure secure local supply and production capacity for critical products for pandemic preparedness