Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will ...

Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of ...

Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy ...

The Journal of Validation Technology is a peer reviewed journal exclusively dedicated to providing practical approaches to conducting effective validations Institute of Validation Technology of ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

A new concept in ampoule packaging, molded entirely of plastic and safe for unlimited consumer use, is available from James Alexander Corporation under the brand name plastiqueAmp A new concept in ...

Source: Sterilization Cassette Systems, Inc.

The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It ...

Occlusion testing using robotic automation for medical devices, such as infusion pumps, catheters, IV lines, insulin pumps, ventilators, and other drug delivery systems, involves robotic systems to ...

Nobody ever said software validation is easy. Like most of you, I was conditioned to accept the “traditional” validation approach, the kind that requires a tremendous amount of documentation, arduous ...

These new swabable luer valves were developed as substitutes for needle ports in IV applications. These new swabable luer valves were developed as substitutes for needle ports in IV applications. They ...