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Zingbox Partners With the Medical Device Innovation, Safety and Security Consortium
Union will deliver key information to enable optimally configured and secured devices for patient safety and privacy.Business Wire 10.10.18
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Survey: 36 Percent of Medical Facilities Still Working to Meet MRI Safety Standards
Data shows many MRI providers are not recording ferromagnetic objects entering MRI rooms.Metrasens 09.05.18
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FDA Releases Medical Device Safety Action Plan in Effort to Modernize Approach
Effort aims to enhance and modernize the FDA’s approach to medical device safety and innovation.Scott Gottlieb, M.D. 04.18.18
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Ten-Year Clinical Study Data Highlight Safety of MENTOR MemoryShape Gel Breast Implants
Latest data show product safety and effectiveness in primary and revision augmentation and reconstruction patients.Johnson & Johnson 03.12.18
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Employee Feedback Should Be Part of a Product Safety Plan
Whistleblower lawsuits in the medtech and pharmaceutical industries are often settled for multiple millions of dollars, but not before they potentially cause harm to patients, caregivers, and quite often, the reputation of manufacturers. How then, ca…Chris Harvey, Director, Recall Solutions, Stericycle Expert Solutions 11.07.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical | Testing
In Pursuit of Device Safety or a Call for Whistleblowers?
Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between t…Sean Fenske, Editor 03.07.17
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Testing
Study Finds Safety Evidence Lacking For 510(k) Devices
A study published in JAMA Internal Medicine claims the U.S. Food and Drug Administration (FDA) has failed to adhere to a law requiring the public disclosure of safety information on new medical devices cleared by the agency. Researchers from the Nat…11.13.14
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R&D & Design | Testing
On the Hill: Device Safety Act Could Have Hodgepodge Effect
Device Safety Act could have hodgepodge effect.Thomas C. Novelli 03.31.09
