AEMPS – Agencia Española de Medicamentos y Productos Sanitarios
AFSSAPS – Agence Française de Sécurité Sanitaire des Produits de Santé (France)
ANSI – American National Standards Institute
ANVISA – The National Health Surveillance Agency (in Portuguese, Agência Nacional de Vigilância Sanitária, ANVISA) is an autonomous organ of the government of Brazil.
ASQC – American Society for Quality Control
Australian Sponsor – An Australian Sponsor is a representative appointed by a non-Australian medical device and IVD manufacturer to act as a contact liaison with the Therapeutic Goods Administration (TGA). An Australian Sponsor must be a resident of Australia or maintain a place of business in Australia.
BOM – Bill of Materials
BSI – British Standards Institute
CA – A Competent Authority is the Department (Ministry) of Health of an EU Member State.
CAPA -Corrective and Preventive Action
CAR – Corrective Action Request or Corrective Action Record
CCC Mark – The China Compulsory Certificate mark, commonly known as CCC Mark, is a safety mark for many products sold on the Chinese market. As of 2013, medical devices do not require this certification.
CCPS – Comunicaciones de Comercialización y/o puesta en servicio de Productos Sanitarios – base de datos de la AEMPS para el registro de productos de la clase IIa, IIb y III y agrupaciones Será sustituida por el Registro de Comercialización RC
CDRH – Center for Devices and Radiological Health (USA)
CE Marking – The CE Marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. By affixing the CE marking to a product, the manufacturer declares that it meets EU safety, health and environmental requirements.
CEN – Communité Européenne des Normes (European Committee for Standardization)
CFR – Code of Federal Regulations (USA)
CFU – Colony Forming Unit (UFC)
cGMP – Current Good Manufacturing Practices. See GMP.
cGMPR – Current Good Manufacturing Practice Regulations
Clinical Trial – Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Clinical Trial Sponsor – The Clinical Trial Sponsor is responsible for the safety of subjects in a clinical trial and informs local site investigators of the true historical safety record of the drug, device or other medical treatment to be tested, and of any potential interactions of the study treatment(s) with already approved medical treatments.
CMDCAS – Canadian Medical Devices Conformity Assessment System
CMDR – Canadian Medical Device Regulation
CNCps – Centro Nacional de Certificación de Productos Sanitarios ON 0318
CR – Change Request
CRF – Change Request Form
CRO – A Contract Research Organization, also called a Clinical Research Organization, is a service organization that provides support to the pharmaceutical and biotechnology industries. CROs offer clients a wide range of «outsourced» pharmaceutical research services to aid in the drug and medical device research and development process.
cGLP – Current Good Laboratory Practice (USA)
CSR – Customer Service Representative
DCMS – Design Change Master Sheet
Design Dossier – See Technical Documentation
DHF – Device History File
DHR – Device History Record
DIMDI – Deutsches Institut für Medizinische Dokumentation und Information (German Institute of Medical Documentation and Information)
DMR – Device Master Record
DTC – Design Transfer Checklist
EC REP – A European Authorized Representative (EC REP) 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 an Regulations.
EDMA – European Diagnostic Manufacturer’s Association
EEA – The European Economic Area includes the 27 European Member States plus Iceland, Liechtenstein and Norway.
EEC – European Economic Community, also referred to as the European Community, which has now become part of the European Union.
EFTA – The European Free Trade Association is a free trade organization between four European Countries (Iceland, Liechtenstein, Norway and Switzerland) that operates parallel to, and is linked to, the European Union.
eLabeling – With the release of European MEDDEV 2.14/3 REV 1 in 2007, the European Commission now allows In-Vitro Diagnostics (IVD) companies with products intended for professional use only to place Instructions for Use online instead of including a printed booklet inside the product packaging.
EMC – Electro-Magnetic Compatibility
EN – European Standards (EN) for various sectors that were created by the European Committee for Standardization (CEN). Some standards are voluntary, whereas other standards are mandatory under EU law.
EU – The European Union is an economic and political union of 27 Member States.
EUDAMED – European Database on Medical Devices
FDA – The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
FENIN – Federación Española de Empresas de Tecnología Sanitaria agrupa a fabricantes y distribuidores establecidos en España
FMEA – Failure Mode and Effects Analysis
FOIA – Freedom of Information Act (USA)
FTA – Fault Tree Analysis
Gap Analysis – Gap analysis is a tool that helps a company to compare its actual performance with its potential performance.
GCP – Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial, assurance of the safety and efficacy of the newly developed compounds, and standards on how clinical trials should be conducted.
GHTF – Global Harmonization Task Force
GMP – Good Manufacturing Practice refers to the quality system requirements for medical device (and other) companies outlined by the US FDA in 21 CFR Part 820. Also referred to as the Quality System Regulation (QSR).
Green Dot – The Green Dot (German: Der Grüne Punkt) is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods as per the European «Packing and Packaging Waste Directive -94/62/EC.» This applies to medical devices as well.
Health Canada – Health Canada is the official regulatory agency that reviews medical devices to assess their safety, effectiveness and quality before they are authorized for sale in Canada.
IDE – An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
IFU – Instructions for Use
ISO 13485 – ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.
ISO 14971 – ISO 14971 is an ISO standard that represents the requirements for a risk management system for medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.
ISO 9001 – ISO 9001 is an ISO standard that represents the requirements for quality management systems. It is used across industries and is not specific to medical devices like ISO 13485.
IVD – In Vitro Diagnostic tests are medical devices intended to perform diagnoses from assays in a test tube, or more generally in a controlled environment outside a living organism.
IVDD – The In Vitro Diagnostic Device Directive delineates requirements that in vitro diagnostic devices must meet before they can be sold in the EU market.
MDD – The Medical Device Directive is intended to harmonize the laws relating to medical devices within the European Union. Medical Device Directive 93/42/EEC was most recently reviewed and amended by 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
MDEL – A Medical Device Establishment License is a certification issued by Health Canada. Class I medical device manufacturers must secure a MDEL if selling directly to Canadian consumers and not through a distributor.
MDR – Medical Device Report (USA)
MDUFMA – Medical Device User Fee and Modernization Act of 2002 (USA)
MDV – Medical Device Vigilance (EU)
Medical Device – A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery.
MHRA – The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Ministry of Health – The health department (or Ministry of Health ) is a part of the government which focuses on issues related to the general health of the citizenry.
MPR – Medical Problem Report (Canada)
MR – Management Representative
MSDS – Material Safety Data Sheet
NCR – Non-Conformance Report
NIH – National Institutes of Health (U.S.)
Notified Body – A Notified Body, in the European Union, is an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture.
OTC – Over the Counter (Patient Use Instructions)
PMA – Premarket approval by FDA is the required process of scientific review to guarantee safety and effectiveness for Class III devices.
PMDA – The Pharmaceutical and Medical Devices Agency in Japan reviews applications for marketing approval of pharmaceuticals and medical devices. It also monitors their post-marketing safety and provides relief compensation for people who have suffered from adverse drug reactions from pharmaceuticals or infections from biological products.
PMPS – aplicación obsoleta de la AEMPS sustituida por la CCPS Comunicaciones de Comercialización y/o puesta en servicio de Productos Sanitarios – base de datos de la AEMPS para el registro de productos de la clase IIa, IIb y III y agrupaciones
PMS – Post Marketing Surveillance is the practice of monitoring a device after it has been released on the market.
PNT – Procedimiento Normalizado de Trabajo
PRRC – PRCN Persona Responsable del Cumplimiento de la Normativa. Cargo según MDR / IVDR del responsable según requisitos de articulo 15
QA – Quality Assurance refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
QMS – Quality Management System can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.
QP – Quality Policy
QSP – Quality System Procedure
QSR – Quality System Regulations. See GMP.
RA – Return Authorization. Can also refer to «Regulatory Affairs.»
RA – Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides,agrochemicals, cosmetics and complementary medicines.
RC – Registro de Comercialización base de datos de la AEMPS para el registro de productos de la clases I, IIa, IIb y III y agrupaciones. Sustituye a la CCPS y RPS que queda solo para ps a medida
Registered Certification Body Japan – Independent companies authorized by the MHLW to certify Specified Controlled Medical Devices and issue Pre-Market Certifications.
Registrar – See Notified Body.
RPS base de datos de la AEMPS para el registro de productos de la clase I que pasa a ser para los ps a medida al entrar en funcionamiento el RC
SOP- Standard Operating Procedure
STED – A Summary TEchnical Document (STED) is a standardized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to standardize regulatory submissions for many countries.
Technical Documentation – is a comprehensive collection of documents that demonstrates a product’s technical basis for conformity to the applicable directive(s). It is required by the CE Marking Directive.
TGA – The Therapeutic Goods Administration is a unit of the Australian Government Department of Health and Ageing that regulates medical devices, IVDs and drugs in Australia.
TR – Técnico Responsable, cargo establecido en la legislación española de productos sanitarios para fabricantes, importadores, agrupadores y distribuidores que precisa titulación universitaria y cuya responsabilidad es la supervisión de las actividades de la instalación
US Agent – A US Agent is a representative is appointed by a non-US medical device of
IVD manufacturer to act as a contact liaison with the US FDA. A US Agent must be a resident of the United States or maintain a place of business in the US.
USP – United States Pharmacopoeia
Validation – Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.
Warning Letter – A warning letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.
WHO – World Health Organization
WI – Work Instructions
WTO – World Trade Organization