Medical software is any software item or system used within a medical context, such as:
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilar. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
CE marking is an administrative marking with which the manufacturer or importer affirms its conformity with European health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It is not a quality indicator or a certification mark. The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense like the FCC Declaration of Conformity used for selling certain electronic devices in the United States.
A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. 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.
The Pressure Equipment Directive (PED) 2014/68/EU of the EU sets out the standards for the design and fabrication of pressure equipment generally over one litre in volume and having a maximum pressure more than 0.5 bar gauge. It also sets the administrative procedures requirements for the "conformity assessment" of pressure equipment, for the free placing on the European market without local legislative barriers. It has been mandatory throughout the EU since 30 May 2002, with 2014 revision fully effective as of 19 July 2016. This is enacted in the UK as the Pressure Equipment Regulations (PER). The set out standards and regulations regarding pressure vessels and boilers safety is also very close to the US standards defined by the American Society of Mechanical Engineers (ASME). This enables most international inspection agencies to provide both verification and certification services to assess compliance to the different pressure equipment directives. From the pressure vessel manufactures PED does not generally require a prior manufacturing permit/certificate/stamp as ASME does.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
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.
A medical laboratory or clinical laboratory is a laboratory where tests are carried out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical Medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. The EU acted to adopt UDI and on April 5, 2017, under the EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), but adoption has been postponed to 2021; see Medical Device Regulation.
ISO 14971Medical devices — Application of risk management to medical devices is an ISO standard for the application of risk management to medical devices. 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 latest significant revision was published in 2019. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard.
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Laboratory developed test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the U.S., were traditionally regulated under the Clinical Laboratory Improvement Amendments program.
Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used,, medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use. Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled “Single Use Device” (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing. Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified commercial vendor. Reprocessing industry estimates indicate the amount of revenue saved by hospitals that use reprocessed devices to be $471 million in 2018. Over 8,800 hospitals and surgical centers use reprocessed devices, in the U.S., Canada, Israel, Europe and Japan, according to the Association of Medical Device Reprocessors.
A technical file is a set of documents that describes a product and can prove that the product was designed and according to the requirements of a quality management system.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
Common specifications are European Union requirements for medical devices, including in vitro diagnostic medical devices (IVD). The specifications are part of the European regulatory framework for medical devices and complement technical requirements in areas where international standards do not exist or do not provide sufficient guidance to comply with the general safety and performance requirements of the MDR and IVDR.
