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Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biomedical Engineering
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes). BME also integrates the logical sciences to advance health care treatment, including Medical diagnosis, diagnosis, Medical monitor, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer. Biomedical engineering has recently emerged as its own field of study, as compared to many other engineering fields. Such an evolution is common as a new field transitions from being an Interdisciplinarity, interdisciplinary specialization among already-established ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Mark
The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental protection Technical standard, standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant European Union law, EU legislation and the product may be sold anywhere in the European Economic Area (EEA) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicinal Product
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in many ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the medical prescription) from over-the-counter drugs (those that consumers can order for themselves). Medicines may be classified by mode of action, route of administration, biological system affected, or therapeutic effects. The World Health Organization keeps a list of essential medicines. Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. As a res ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Competent Authority
A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function. Similarly, once an authority is delegated to perform a certain act, only the competent authority is entitled to take accounts therefrom and no one else. Borrowing authority when the services of a certain class of individuals are entrusted to one of the authority other than the appointing authority, the former will be the borrowing authority. Borrowing Authority will be authorised to look into the performance of individuals with respect to the task so assigned to them. Borrowing authority, service conduct when it appears to the borrowing authority the conduct of the individuals not in accordance with the standard prescribed, it will move in writing to the appointing authority the conduct so observed with the evidence so brought on record for proceedings therein. Appointing authority, however, is not competent to proceed aga ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ... (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, EUDAMED registration, and increased post-market surveillance activities. Classification The regulation introduces, in §47, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Immunology
Immunology is a branch of biology and medicine that covers the study of Immune system, immune systems in all Organism, organisms. Immunology charts, measures, and contextualizes the Physiology, physiological functioning of the immune system in states of both health and diseases; malfunctions of the immune system in immunological disorders (such as Autoimmune disease, autoimmune diseases, Hypersensitivity, hypersensitivities, immune deficiency, and transplant rejection); and the physical, chemical, and physiological characteristics of the components of the immune system ''in vitro'', ''In situ#Biology and biomedical engineering, in situ'', and ''in vivo''. Immunology has applications in numerous disciplines of medicine, particularly in the fields of organ transplantation, oncology, rheumatology, virology, bacteriology, parasitology, psychiatry, and dermatology. The term was coined by Russian biologist Ilya Ilyich Mechnikov, who advanced studies on immunology and received the Nob ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Pharmacopoeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription, over-the-counter, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in US federal law; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity. USP also ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Formulary
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication (a resource closer to what would be referred to as a pharmacopoeia today). Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs. Depending on the individual formulary, it may also contain additional clinical information, such as side effects, contraindications, and doses. By the turn of the millennium, 156 countries had national or provincial essential medicines lists and 135 countries had national treatment. Austra ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
In Vitro Diagnostics
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic testing, chemical and cellular analysis, relating to clinical chemistry and molecular diagnostics, are typically performed in a medical setting. Types of tests By purpose Medical tests can be classified by their purposes, including diagnosis, screening or monitoring. Diagnostic A diagnostic test is a procedure performed to confirm or determine the presence of disease in an individual suspected of having a disease, usually following the report of symptoms, or based on other medical test results. This includes posthumous diagnosis. Examples of such tests are: * Using nuclear medicine to examine a patient suspected of having a lymphoma. * Measuring the blood sugar in a person suspected of having diabetes mellitus after periods of in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
