The tension between reliability and cost has never been higher in robotically assisted surgery. Read this article for tips on ...

Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to ...

Accumold is a leader in precision micro-molding, offering unparalleled expertise in the production of high-quality micro plastic components for industries such as medical, electronics, automotive, and ...

As the world contends with a growing number of extreme weather events and global shipping routes are increasingly impacted by geopolitical strife, supply chain challenges have surged. Thus, ...

The FDA’s final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023. While the ...

The issue of misuse of medical devices is a major one. Whether it happens by patients using a device at home without proper training or by surgical staff looking for a faster way to operate a device, ...

FDA’s recent issuance of a final rule 1 (the “rule”) on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with regard to medical device ...

The MathWorks, Inc. has unveiled a new version of its DSP Workshop The MathWorks, Inc. has unveiled a new version of its DSP Workshop. The new version, which is based on the updated MATLAB 5.2 and ...

Over the past few years, the medical device manufacturing industry has witnessed a significant shift towards the use of Radio-Frequency Identification (RFID) technology. Many Original Equipment ...

One of the most common immunoassay formats for in vitro diagnostics (IVD) is the lateral flow assay (LFA). Antibodies play a crucial role, as their quality attributes and interaction with antigens ...