Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

PITTSBURGH--(BUSINESS WIRE)--Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated ...

A few short months from now, manufacturers of Class III medical devices must comply with FDA’s unique device identification (UDI) rule. Part 1 of this series focused on the need for companies to start ...

The Food and Drug Administration last week released an amendment to its proposed rule for a unique device identification system released in July. The amendment shortens the originally proposed ...

In today’s world – whether at work or at home – I’d be lost without the smartphone that helps me do so much more than just communicate. It knows where I am now and how to get where I want to be next.

Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure ...

VOORHEES, N.J., July 8, 2025 /PRNewswire/ -- Comar, a leader in healthcare packaging, has achieved CE certification under the EU Medical Device Regulation (EU MDR 2017/745), reaffirming its commitment ...

CHICAGO--(BUSINESS WIRE)--The Society for Vascular Surgery® Vascular Quality Initiative® (SVS VQI), a nonprofit organization dedicated to improving vascular quality within hospitals and outpatient ...