Dublin, Nov. 13, 2020 (GLOBE NEWSWIRE) -- The "Medical Device & IVD Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 - 2030" report has ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices ...

More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...

RALEIGH, N.C.--(BUSINESS WIRE)--Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ...

MADISON, Wis.--(BUSINESS WIRE)--Promega Corporation today announced it plans to develop and commercialize a microsatellite instability (MSI) companion diagnostic (CDx) IVD kit with GSK to identify ...

WASHINGTON, Oct. 31, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory ...

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in ...

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...

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 ...

The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...