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.
Medcrypt's FDA Cybersecurity Readiness Services helps medical device manufacturers comply with the FDA's new Refuse to Accept and Section 524B requirements.
The U.S. FDA’s draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks globally.
The new advisory highlights the importance of how surgical instruments and other critical devices are reprocessed and reused every day in healthcare.
Medcrypt's FDA Cybersecurity Readiness Services helps medical device manufacturers comply with the FDA's new Refuse to Accept and Section 524B requirements.
As the Right to Repair movement gains momentum, a Proto article asks, should hospitals be allowed to fix machines themselves?
Read MoreOlympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.
Read MoreThe 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.
Read MoreThe 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.
Read MoreNot 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.
Read MoreThe 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.
Read MoreThe 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.