The Medical Device Single Audit Program (MDSAP) enables manufacturers to align their quality management systems with regulatory standards across key markets like Australia, Brazil, Canada, Japan, and ...

WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has successfully achieved ISO 13485:2016 Medical Device Quality ...

The medical device industry stands at a critical inflection point. As healthcare costs continue to spiral upward and demands for transparency intensify, the need for comprehensive asset visibility and ...

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set ...

DUBLIN--(BUSINESS WIRE)--The "Risk Management in Medical Devices Industry" conference has been added to ResearchAndMarkets.com's offering. Risk management is a mandatory and necessary process during ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products" conference to their offering.

INDIANAPOLIS, Nov. 25, 2019 /PRNewswire-PRWeb/ -- Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today announced findings from the "State of Medical ...

Supply chain leaders and managers in the medical device industry are often puzzled by the multitude of strategies, corporate directives, and transformation programs that claim to improve the ...

As cardiac technology continues to advance, medical device developers are working rapidly to bring new implantable cardiovascular devices to market. When preparing for a clinical trial, there are ...