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Work instructions contained in two device master records were incorrect and the company did not maintain its electronic device master records as instructed by its procedure. Read More
Efforts by hospitals to improve cybersecurity for medical devices often run up against unsecured legacy systems and the patching necessary to resolve the security flaws often impede the device’s function. Read More
The trial system is an extension of the Axionics sacral neuromodulation system and is used to help identify patients responsive to sacral neuromodulation therapy before a permanent implant is installed. Read More
The new inspection program will supplement the authority’s existing inspections aimed at prevention and control of healthcare-associated infections. Read More
Single-shot ablation therapies, which deliver blasts of heat or cold to areas of the heart responsible for abnormal rhythm, are thought to be the quickest growing subcategory in the global electrophysiology market. Read More
Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida facility. Read More