Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
Globally aware CEOs are looking beyond rich country patients for long-term growth. This article highlights a pair of startups attempting to bring innovation large, under-served populations, and analyzes the effectiveness of their approach.
This article provides an in-depth and comprehensive explation one of the most broadly applicable and durable root cause analysis tools to investigate the quality of your manufacturing processes: the fishbone diagram.
The hip and knee replacement markets in India and China currently are underserved, and present tremendous opportunities for large joint device manufacturers.
One topic that often generates confusion — and sometimes heated debate — is whether study participants should be trained on a product’s use prior to testing. Trained participants may be more likely to use the product as intended during testing but, as testing is intended to simulate real-life product use, training may not always be appropriate.
Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.
Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance.
Three potential paths exist when seeking regulatory approval in both the European Union and the United States: E.U. first, U.S. first, and simultaneous. The simultaneous approach, while seemingly complicated, streamlines the process, condenses the documentation, and reduces time to market.
Rising demand for electronic components -- driven by the automotive, defense, aerospace, and industrial manufacturing industries -- could create supply challenges like price volatility, counterfeiting, relabeling, selling out-of-date parts, and double- or triple-booking orders
Companies developing new healthcare products for Millennials have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.
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