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IDEAL (Idea, Development, Exploration, Assessment, Long-term study) is a framework for describing the stages of innovation in surgery and other interventional procedures.. The purpose of IDEAL is to improve the quality of research in surgery by emphasizing appropriate methods, transparency of data and rigorous reporting of outcom
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]
The study was influential in shaping public perceptions of research involving human subjects. After the press exposed the study, the US Congress appointed a panel that determined that the study should be stopped immediately and that the oversight of human research was inadequate. The panel recommended that federal regulations be designed and ...
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.
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.
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
Cell culture vials The University of Florida Cancer and Genetics Research Complex is an integrated medical research facility.. Medical research (or biomedical research), also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.