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Millions of People Used Tainted Breathing Machines The FDA Failed to Use Its Power to Protect Them

The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs, says a ProPublica.

North carolinaUnited statesBaton rougeTess schulmanRita redbergPaul pelletierJeff shurenMichael gonzalezMadris kinardPhilips respironicsRichard ieyoubLarry kesslerDevice innovation consortiumJustice departmentMembers of congressAssociation for the advancement of medical instrumentation

How the FDA Failed to Protect Millions of People From Tainted Breathing Machines — ProPublica

The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs. New reporting shows the regulatory lapses extend to many devices and companies.

New yorkUnited statesBaton rougeSilver springNorth carolinaKelly adkinsHaajrah gilaniRichard ieyoubMolly burkePaul pelletierTess schulmanMadaleine rubinPhilips respironicsMichael gonzalezMonica sagerLiz moughon propublica

Biomedical Engineers Expand Skillsets Through Clinical Program

'There’s no other program like this in the country. We’re giving them real world experience while they work towards a master’s degree'

United statesHartford hospitalRhode islandTrinity collegeNew yorkHartford graduate centerSaint francisYale new haven hospitalRensselaer polytechnic instituteFort detrickLos angelesNew jerseyUconn storrsAtlantic statesDanielle mcgearyChristopher larosa danielle mcgeary

How To Make The FDA Happy 7 Medtech Design Pro Tips For Combination Products

How To Make The FDA Happy 7 Medtech Design Pro Tips For Combination Products
meddeviceonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from meddeviceonline.com Daily Mail and Mail on Sunday newspapers.

United statesTom kramerAmerican national standardAssociation for the advancement of medical instrumentationEuropean medicines agencyKnow yourValidation itemsConduct your summative studiesQuality system regulationProperly manage your designMedical instrumentationProvide yourAvoid human factors engineeringNational standardRegulatory differences that are most likelyUse failure modes

FDA Gives Full Recognition to AAMI Cybersecurity Guidance Document

FDA Gives Full Recognition to AAMI Cybersecurity Guidance Document
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

Matt williamsDrug administrationAssociation for the advancement of medical instrumentationMedical instrumentation