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ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Orphan drug – a drug used to treat a rare medical condition, or orphan disease; Placebo – a sham treatment given to a control group in a clinical study; Prescription drug – a licensed medicine that can only be obtained by prescription from a doctor; Standard treatment – a currently available drug used in an active control clinical study
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health.
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
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Medical halogen penlight: to see into the eye, natural orifices, etc. and to test for pupillary light reflex, etc. Medical ultrasound: to create an image of internal body structures Nasogastric tube: for nasogastric suction or the introduction of food or drugs into the body Nebulizer: to produce aerosols of drugs to be administered by ...