device safety การใช้

• There are also market withdrawals and medical device safety alerts '.
• Since December 2014, Fitzpatrick has been a leading voice in Congress on medical device safety.
• Medical device safety alerts occur when there are unreasonable safety risks associated with using a product.
• Thus, the RADAR project has developed into an important adjunct to the current pharmaceutical drug and device safety system.
• Through a draft guidance, FDA has introduced another method named " Safety Assurance Case " for medical device safety assurance analysis.
• The company did not ask the France's medical device safety regulators for approval of their in house manufactured product, but expected it would have gotten approval if the company asked for it.
• Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.
• Ultimately, says Dr Hoffman, the process of ensuring device safety will continue to be compromised unless the thorny problem of interference from politicians and industry is tackled . " None of this occurs in a vacuum, of course.
• The Australia New Zealand Therapeutic Products Authority ( ANZTPA ) will replace the Australian Therapeutic Goods Administration ( TGA ) and the New Zealand Medicines and Medical Devices Safety Authority ( Medsafe ), and be accountable to the Australian and New Zealand Governments.