Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, 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.
Medical physics deals with the application of the concepts and methods of physics to the prevention, diagnosis and treatment of human diseases with a specific goal of improving human health and well-being. Since 2008, medical physics has been included as a health profession according to International Standard Classification of Occupation of the International Labour Organization.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
GE HealthCare Technologies, Inc., doing business as GE HealthCare, is an American multinational medical technology company headquartered in Chicago, Illinois. It was spun-off from General Electric on January 4, 2023, with GE retaining 10.24%. As of 2017, it is a manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities used in medical imaging procedures. It offers dyes used in magnetic-resonance-imaging procedures; manufactures medical diagnostic equipment, including CT image machines; MRI, XRAY; Ultrasound; Cath Labs; Mammogram; Nuclear Medicine Cameras; and develops Health technology for medical imaging and information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery, and biopharmaceutical manufacturing. It was incorporated in 1994 and operates in more than 100 countries.
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.
Omron Corporation, styled as OMRON, is a Japanese electronics company based in Kyoto, Japan. Omron was established by Kazuma Tateisi (立石一真) in 1933 and incorporated in 1948.
Medical 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.
The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.
Saint Petersburg State Institute of Technology (Technical University) (Russian: Санкт-Петербургский Технологический Институт (Технический Университет)) was founded in 1828. It is one of the oldest institutions of higher education in Russia, and currently trains around 5,000 students.
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), formerly Sree Chitra Tirunal Medical Center, is an Institution of National Importance in India established in 1976 at Thiruvananthapuram, Kerala. The institute is a statutory body under Ministry of Science and Technology and is under the Administrative Control of the Department of Science and Technology, Government of India. SCTIMST is one of the most prominent research Institutes and centers in India.
The European Medical Devices Industry Group (EMIG) is a non-profit trade association, and represents the medical devices industry in Europe as defined by the European Union Medical Devices Directives (93/42/EEC). Karen Howes is the current chair person of EMIG.
Eucomed was the organisation that represented the interests of the medical device industry in Europe. It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. Eucomed represents a total of 11,000 legal entities in Europe. It is now part of MedTech Europe.
ISO 14971Medical devices — Application of risk management to medical devices is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971.
AdvaMed, or the Advanced Medical Technology Association, is an American medical device trade association, based in Washington, D.C. It is the largest medical device association in the world with U.S. and international members who are medical technology companies that collectively represents 80% of U.S. medical technology firms in the United States, that produce close to 90% of annual health care technology purchases in the United States and more than 40% globally.
The pharmaceutical industry in Switzerland directly and indirectly employs about 135,000 people. It contributes 5.7% of the gross domestic product of Switzerland and 30% of the country's exports. In 2017 about 30% of Swiss exports were chemical products. In the same year Switzerland was the second largest exporter of packaged medicine in the world, with about 11% of the global total, worth $36.5 billion.
MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. It represents Diagnostics and Medical Devices manufacturers operating in Europe. It is born as an alliance of two European medical technology associations, EDMA and Eucomed, representing the European IVD and medical device industries, respectively. It was established with the aim to represent the common policy goals of both organisations more effectively, promoting the interests of its members and of the medical technology industry in general. There are more than 33,000 medical technology companies in Europe. The highest number of them are based in Germany, followed by Italy, the UK, France and Switzerland.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Andhra Pradesh MedTech Zone(AMTZ) is the medical technology park with Common Manufacturing Facilities & Common Scientific Facilities located in Nadupuru village area of Visakhapatnam, adjacent to the Visakhapatnam Steel Plant. The AMTZ is spread over an area of 270 acres and it has over 10 manufacturing units.
The European Federation of Organisations for Medical Physics (EFOMP) was founded in May 1980 in London to serve as an umbrella organisation representing the national Medical Physics societies in Europe. The office moved to Utrecht in January 2021. It is a non-profit organisation and aims to foster and coordinate the activities of its national member organisations, encourage exchange and dissemination of professional and scientific information, develop guidelines for education, training and accreditation programmes and to make recommendations on the responsibilities, organisational relationships and roles of medical physicists.
