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)
ACE - Adverse Clinical Event
ACT - Applied Clinical Trials
AFSSAPS - Agence FranÃ§aise de SÃ©curitÃ© Sanitaire des Produits de SantÃ© (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.
BOM - Bill of Materials
BSI - British Standards Institute
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 - ConformitÃ© EuropÃ©enne (European Conformity)
CE Mark/CE Marking - The official â€œpassport stampâ€ that tells European Competent Authorities your product has met the appropriate Directives.
CEN - CommunitÃ© EuropÃ©enne 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
DCMS - Design Change Master Sheet
DHF - Device History File
DHHS - Department of Health and Human Services (USA)
DHR - Device History Record
DIMDI - Deutsches Institut fÃ¼r 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
EDMA - European Diagnostic Manufacturerâ€™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
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
GHTF - Global Harmonization Task Force
Green Dot - A packaging reuse and recycling scheme for Europe and Canada.
Health Canada - Official regulatory agency for medical devices in Canada.
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
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 Manufacturerâ€™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
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
OSHA - Occupational Safety and Health Administration (USA)
OTC - Over the Counter (Patient Use Instructions)
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
QA - Generally stands for â€œQuality Assurance.
QC - Quality Control
QPM - Quality Policy Manual
QSP - Quality System Procedure
QSR - Quality System Regulations
RA - Generally means â€œRegulatory Affairs.â€
RA - Return Authorization (note: can also refer to â€œRegulatory Affairsâ€ in general)
Registrar - See Notified Body.
SOP - Standard Operating Procedure
Sponsor - A company or person that acts as official representative to the Australian TGA.
SRW - Shipping Receiving Warehouse
TGA - Therapeutic Goods Administration. Regulates all medical devices and drugs in Australia.
Technical File/Dossier - Document that demonstrates a productâ€™s technical basis for conformity to the applicable directive(s).
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
WHO - World Health Organization
WI - Work Instructions
WTO - World Trade Organization
Training and Workshops
Omnex Systems Webinar - Managing Audits Globally Using Best Practices - October 29, 2005 (12 MB Webex file)
Download Complete Global Medical Device Regulations and Information
13485:2003 Lead Auditor Training
ISO 13485:2003 Internal Auditor Training
ISO 13485:2016 Lead Auditor Training
ISO 13485 Training
ISO 13485:2016 Internal Auditor Training
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