Quality management systemSum of product fitness processes in a business A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction, and is expressed as organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain them.
IEC 62304IEC 62304 – medical device software – software life cycle processes is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.
Medical Devices DirectiveThe Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met.
SoftwareSoftware (SW) consists of computer programs that instruct the execution of a computer. Software also includes design documents and specifications. The history of software is closely tied to the development of digital computers in the mid-20th century. Early programs were written in the machine language specific to the hardware.
Medical robotA medical robot is a robot used in the medical sciences. They include surgical robots. These are in most telemanipulators, which use the surgeon's activators on one side to control the "effector" on the other side.
Electronic health recordAn electronic health record (EHR) is the systematized collection of electronically stored patient and population health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges.
Food and Drug AdministrationThe Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services (HHS).
CardiologyCardiology (from Ancient Greekκαρδίᾱ (kardiā)'heart' and -λογία ()'study') is the study of the heart. Cardiology is a branch of medicine that deals with disorders of the heart and the cardiovascular system, and it is a sub-specialty of internal medicine. The field includes medical diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease, and electrophysiology.Therac-25Radiotherapy machine involved in six accidents Therac 25 Machine The Therac-25 was a computer-controlled radiation therapy machine produced by Atomic Energy of Canada Limited (AECL) in 1982 after the Therac-6 (neptune) and Therac-20 units (the earlier units had been produced in partnership with Compagnie générale de radiologie (CGR) of France).
HospitalA hospital is a healthcare institution providing patient treatment with specialized medical science and auxiliary healthcare staff and medical equipment. The best-known type of hospital is the general hospital, which typically has an emergency department to treat urgent health problems ranging from fire and accident victims to a sudden illness.
Lockheed CorporationThe Lockheed Corporation was an American aerospace manufacturer. Lockheed was founded in 1926 and merged in 1995 with Martin Marietta to form Lockheed Martin. Its founder, Allan Lockheed, had earlier founded the similarly named but otherwise-unrelated Loughead Aircraft Manufacturing Company, which was operational from 1912 to 1920.
Nuclear medicineNuclear medicine (nuclear radiology) is a medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease. Nuclear imaging is, in a sense, radiology done inside out, because it records radiation emitted from within the body rather than radiation that is transmitted through the body from external sources like X-ray generators.
PacemakerMedical device for artificially stimulating heart contractionsMedical interventionA pacemaker, also known as an artificial cardiac pacemaker, is an implantedmedical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to contract and pump blood, thus regulating the function of the electrical conduction system of the heart.*As an Amazon Associate I earn from qualifying purchases.