Yash Siddhartha, Flexan’s President, Medical Device Solutions (MDS), discussed with Med Device Online his vision for the ...

Qosina offers caps in a variety of sizes and styles; including Male and Female, Vented and Non-Vented, Double Dead Enders, Large Bore, and more. OEM single-use caps are stocked in a range of materials ...

ResMed's S7 Lightweight complements the S7 Elite and AutoSet SpiritTM, providing the clinician and dealer with the benefits of a comprehensive CPAP line for the treatment of OSA. S7 Lightweight is ...

A large global medical device manufacturer invented a new textile structure to improve the performance of one of their orthopedic devices. One of the critical parameters identified for the component ...

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 ...

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, ...

FDA’s harmonization of the Quality System (QS) Regulation with ISO 13485 was long expected. It is welcomed by the global medtech companies, as other jurisdictions like the EU already use ISO 13485 as ...

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 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Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023.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 ...