Latest From Siemens AG
Not Your Grandfather’s CAPA: Case For Quality Pilot Gives Corrective And Preventive Action A Facelift
Big changes are afoot when it comes to CAPA. Ten medtech manufacturing sites are playing in a pilot program that uses a novel framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA. Medtronic quality/regulatory expert Kathryn Merrill weighs in.
Smiths Medical is increasing paraPAC ventilator production from hundreds to thousands a month to fulfill 10,000 units as part of the Ventilator Challenge UK consortium.
Market Intel: Hearing-Aid Companies' Use Of AI, Apps, New Tech Excites Audiologists; Global Hearing-Aid Market Will Reach $11Bn By 2023
Hearing-aid manufacturers are using AI, apps and other new technologies to create devices that are more sophisticated, smaller and more programmable. According to a new report by Informa's Meddevicetracker, the global market for hearing aids will reach $11by by 2023. This article offers an in-depth look at the competitive landscape, products as well as trends, such as new US FDA regulations for over-the-counter hearing aids and devices with language translation capabilities, with key insights from two audiologists.
Siemens Cybersecurity Expert Says Medtech Industry Has 'Perverse Incentive' To Not Disclose Vulnerabilities – Might A New Law Be The Fix?
The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."
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