Search results
Results from the WOW.Com Content Network
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 Iyaku-hin, iryō-kiki tō no hinshitsu, yūkōsei oyobi anzensei no kakuho tō ni kansuru hō ritsu) is a law regulating the manufacturing, importation, and sale of drugs, medical devices and ...
Safe Medical Device Amendments of 1990; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. Enacted by: the 101st United States Congress: Effective: November 28, 1990: Citations; Public law: 101-629: Statutes at Large: 104 Stat. 4511 ...
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products; Research on the development of industry standards; Victim compensation:
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
In health care, diagnosis codes are used as a tool to group and identify diseases, disorders, symptoms, poisonings, adverse effects of drugs and chemicals, injuries and other reasons for patient encounters. Diagnostic coding is the translation of written descriptions of diseases, illnesses and injuries into codes from a particular classification.
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...