Medcrypt Launches Services to Navigate FDA’s New Cybersecurity Rules
Medcrypt's FDA Cybersecurity Readiness Services helps medical device manufacturers comply with the FDA's new Refuse to Accept and Section 524B requirements.
Tag: FDA medical device safety
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FDA Official: Draft Cybersecurity Guidance Has ‘Teeth’
The U.S. FDA’s draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks globally.
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Joint Commission Issues Safety Advisory on Critical Instruments, Medical Devices
The new advisory highlights the importance of how surgical instruments and other critical devices are reprocessed and reused every day in healthcare.
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Medcrypt Launches Services to Navigate FDA’s New Cybersecurity Rules
Medcrypt's FDA Cybersecurity Readiness Services helps medical device manufacturers comply with the FDA's new Refuse to Accept and Section 524B requirements.
Who Has the Right to Repair Medical Equipment?
As the Right to Repair movement gains momentum, a Proto article asks, should hospitals be allowed to fix machines themselves?
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Olympus Supports New FDA Guidance on Bronchoscope Reprocessing
Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.
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FDA Wants to Require Timely Updates, Patches for Legacy Devices: Cyber Chief
The U.S. FDA’s first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency’s regulatory policy can help improve it.
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FDA Issues Updated Recommendations for Bronchoscope Reprocessing
The U.S. FDA has issued a safety communication providing new recommendations for bronchoscope reprocessing and other new information about bronchoscope medical device adverse event reports.
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Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
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FDA: Stop New Implants of Medtronic Ventricular Assist Device System
The U.S. FDA is alerting healthcare providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device System due to safety concerns.
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FDA Seeks 8% Budget Boost for CDRH to Back Resurgence of Domestic Device Production
The U.S. FDA is proposing an increased Center for Devices and Radiological Health budget that would focus on fixing shortages and supply chain issues, reports MedTech Dive.
