The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

At the SPS 2024 event Nuremberg, Germany, ODVA announced two new updates for EtherNet/IP. The first announcement relates to the enhancement of CIP Safety on EtherNet/IP to allow for the use of ...

Process safety is about understanding hazards and risk, managing risk by providing the appropriate layers of protection to reduce the frequency and severity of incidents, and learning from incidents ...

Welcome to the Automation World Gets Your Questions Answered podcast. I’m David Greenfield, editor in chief at Automation World and in this episode, I’ll be looking at the basic safety device types ...

Eight serious loopholes and cracks in the U.S. Food and Drug Administration's approval process allow potentially unsafe, ineffective yet high-risk machines and materials to be approved for use on ...

The regulatory landscape for process industries in the United States became a little more onerous earlier this year. On February 21, 2020, the U.S. Chemical Safety and Hazard Investigation Board (CSB) ...

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

Surface modification of medical devices allows manufacturers to maintain the mechanical properties of materials while adding specific functionalities at biological interfaces. This optimization is ...

FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process Last week FDA released two statements ...