Medical Device Failure

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related...

Medical Device Safety | FDA

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other …

Medical Device Makers Report Malfunctions …

https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

But the hidden database has included serious injury and malfunction reports for about 100 medical …

Seven serious medical device malfunctions that have led …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

The grim stories behind seven of medtech’s …

https://www.medicaldesignandoutsourcing.com/the-grim-stories-behind-seven-of-medtechs-worst-failures/

Medical devices save or restore thousands of patient lives every year, but the dark side to medtech …

7 Recent Medical Device Failures Catching …

https://www.mddionline.com/7-recent-medical-device-failures-catching-fdas-eye

1. Inadequate Sterilization for an Orthopedic Surgery Tool The FDA is warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because …

Five Common Causes of Medical Device …

https://www.mddionline.com/testing/five-common-causes-medical-device-failure

Medical device failures can be disastrous, but they can be quickly resolved if a company takes immediate action to determine the cause of failure. Below is a list …

Epic Fails in Medical Device History

https://www.medreps.com/medical-sales-careers/epic-fails-in-medical-device-history

Epic Fails in Medical Device History March 27, 2017 pixabay It’s never a good thing when medical devices fail. Not only is patient health at risk, in many …

Medical Device Failures | Simon Law

https://simonlawpc.com/medical-malpractice/medical-device-failures/

Common medical devices that have seen failures in their history include body implants, insulin pumps, body monitors, stimulators, defibrillators, medical …

The Top 7 Reasons Why Medical Devices …

https://boydbiomedical.com/articles/the-top-7-reasons-why-medical-devices-fail

1) Medical device startup owners fail to assemble competent teams Research indicates that approximately 75% of medical device companies fail or …