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

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

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 ...

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, ...

It looks like things will be heating up in 2025 from a regulatory perspective for the medical device industry. Several rules and regulations have important due dates in 2025 and beyond for which ...

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, ...

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Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023.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

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 ...