ISO 13485 | Medical Device Quality and Regulatory Acronyms and Terms
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Index of Medical Device Quality and Regulatory Acronyms and Terms

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510(k) - Application submitted to the US FDA
513(g) - Application submitted to the US FDA for device classification
98/79/EC - In Vitro Diagnostic Devices Directive (Europe)
93/42/EEC - Medical Devices Directive (Europe)
90/385/EEC - Active Implantable Medical Devices Directive (Europe)

A

ACE - Adverse Clinical Event
ACT - Applied Clinical Trials
AFSSAPS - Agence Française de Sécurité Sanitaire des Produits de Santé (France)
AIMDD - Active Implantable Medical Device Directive
ANSI - American National Standards Insitute
ASQ - American Society for Quality
ASL - Approved Supplier List
Authorized Representative (AR) - A company or person that acts your official representative in Europe.

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B

BOM - Bill of Materials BSI - British Standards Institute

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C

CAPA - Corrective and Preventive Action
CAR - Corrective Action Request OR Corrective Action Record
CDC - Centers for Disease Control & Prevention (USA)
CDRH - Center for Devices and Radiological Health (USA)
CE - Conformité Européenne (European Conformity)
CE Mark/CE Marking - The official “passport stamp” that tells European Competent Authorities your product has met the appropriate Directives.
CEN - Communité Européenne des Normes (European Committee for Standardization)
CFR - Code of Federal Regulations (USA)
CFU - Colony Forming Unit (used in Gamma validation)
cGLP - Current Good Laboratory Practice (USA)
cGMP - Current Good Manufacturing Practices. Also known as GMP.
cGMPR - Current Good Manufacturing Practice Regulations
Class 1 device - Low risk medical devices
Class 1 measuring - Low risk medical devices with a measuring function
Class 1 sterile - Low risk devices, but different requirements to maintain sterility.
Class 2a/2b medical device - Includes a wide range of medium risk medical devices.
Class 3/4 medical device - High risk devices. Class 4 is used assigned in Canada only.
CMDR - Canadian Medical Devices Regulations
CMDCAS - Canadian Medical Devices Conformity Assessment System
Competent Authority (CA) - The individual National Ministries of Health in Europe.
CR - Change Request
CRF - Change Request Form
CSR - Customer Service Representative

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D

DCMS - Design Change Master Sheet
DHF - Device History File
DHHS - Department of Health and Human Services (USA)
DHR - Device History Record
DIMDI - Deutsches Institut für Medizinische Dokumentation und Information (Germany)
DIMS - Design Input Master Sheet
DMR - Device Master Record
DRMS - Design Review Master Sheet
DTC - Design Transfer Checklist
DVMS - Design Validation Master Sheet
DVerMS - Design Verification Master Sheet

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E

EDMA - European Diagnostic Manufacturer’s Association
EEA - European Economic Area. Includes 25 European Union states plus Norway, Iceland and Liechtenstein.
EEC - European Economic Community
EFTA - European Free Trade Association
EMC - Electro-Magnetic Compatibility
EN - European Standard
EU - European Union. The association of 25 member countries in Europe.
EUCOMED - European Confederation of Medical Associations
EUDAMED - European Database on Medical Devices

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F

FDA - Food and Drug Administration. Regulates all devices in the USA, among other things. FMEA - Failure Mode and Effects Analysis FOIA - Freedom of Information Act (USA) FTA - Fault Tree Analysis

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G

GHTF - Global Harmonization Task Force Green Dot - A packaging reuse and recycling scheme for Europe and Canada.

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H

Health Canada - Official regulatory agency for medical devices in Canada.

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I

ID - Identification
IDE - Investigational Device Exemption
IFU - Instructions for Use
ISO - International Standards Organization
ISO 13485 - International quality management standard for the medical device sector
ISO 14971 - Risk management standard. Often applied in conjunction with ISO 13485
ISO 9001 - International quality management standard
IVD - In Vitro Diagnostic
IVDD - In Vitro Diagnostic Directive. European quality Directive known as 98/79/EC

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M

MDD - Medical Device Directive. European quality assurance regulation known as 93/42/EEC
MDEL - Medical Device Establishment Licensing. Required by Canadian government for companies selling their medical devices there.
MDMA - Medical Device Manufacturer’s Association
MDR - Medical Device Reporting (USA)
MDUFMA - Medical Device User Fee and Modernization Act of 2002 (USA)
MDV - Medical Device Vigilance (EU)
MHRA - Medical and Healthcare Products Regulatory Agency (U.K.)
MPR - Medical Problem Report (Canada)
MR - Management Representative
MSDS - Material Safety Data Sheet

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N

NA - Not Applicable
NCR - Non-Conformance Report
NIH - National Institutes of Health (U.S.)
Notified Body - Organization nominated by European countries to provide services to determine conformity to the New Approach Directives, including medical devices and IVDs.
NPRA - New Product Risk Assessment

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O

OSHA - Occupational Safety and Health Administration (USA)
OTC - Over the Counter (Patient Use Instructions)

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P

PMA - Pre-Market Approval. Required by the FDA for high risk devices to guarantee safety and effectiveness.
PMN - Pre Market Notification, also known as a 510(k) application to the FDA.
PO - Purchase Order
PRMS - Product Requirements Master Sheet

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Q

QA - Generally stands for “Quality Assurance.
QC - Quality Control
QPM - Quality Policy Manual
QSP - Quality System Procedure
QSR - Quality System Regulations

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R

RA - Generally means “Regulatory Affairs.”
RA - Return Authorization (note: can also refer to “Regulatory Affairs” in general)
Registrar - See Notified Body.

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S

SOP - Standard Operating Procedure
Sponsor - A company or person that acts as official representative to the Australian TGA.
SRW - Shipping Receiving Warehouse

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T

TGA - Therapeutic Goods Administration. Regulates all medical devices and drugs in Australia.
Technical File/Dossier - Document that demonstrates a product’s technical basis for conformity to the applicable directive(s).

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U

US Agent - Representative appointed by a non-US medical, drug, food or cosmetic manufacturer to act as a contact liaison to the US FDA.
USP - United States Pharmacopoeia

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W

WHO - World Health Organization
WI - Work Instructions
WTO - World Trade Organization

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