Have you ever wondered what all of those acronyms mean?
The ins and outs of the medical industry are complicated enough as it is. Understanding the science, the different technologies, and the regulations required to get a product to market is already a full plate. By throwing word abbreviations into the mix, it adds a whole new level of difficulty. To simplify one aspect of medical manufacturing, here is a glossary to help translate some of the industry’s most common acronyms. To simplify the other aspects of medical manufacturing, unfortunately a blog post won’t do it (But an Averna Engineer will)!
| 510(k) - Premarket Notification | HSE - Health and Safety Executive |
| AIMDD - Active Implantable Medical Devices Directive | IDE - Investigational Device Exemption |
| ANDA - Abbreviated New Drug Application | IQ - Installation Qualification |
| ASTM - American Society for Testing and Materials | ISO - International Organization for Standardization |
| BOM - Bill of Materials; | IVD - In Vitro Diagnostic |
| CAD - Computer-Aided Design | IVDD - In Vitro Diagnostic Medical Devices Directive |
| CAM - Computer-Aided Manufacturing | IVDR - In Vitro Diagnostic Medical Devices Regulation |
| CAPA - Corrective and Preventive Action | MDD - Medical Devices Directive |
| CE - Conformité Européenne | MDQMS - Medical Device Quality Management System |
| CEP - Certificate of Suitability of Monographs of the European Pharmacopoeia | MDR - Medical Devices Regulation |
| CNC - Computer Numerical Control | MEDDEV - Medical Device Guidelines; |
| DHF - Design History File | MRP - Material Requirements Planning |
| DHR - Device History Record | NB - Notified Body |
| DICOM - Digital Imaging and Communications in Medicine | NDA - New Drug Application |
| DMR - Device Master Record | NHS - National Health Service |
| EDI - Electronic Data Interchange | NIST - National Institute of Standards and Technology |
| EDQM - European Directorate for the Quality of Medicines & HealthCare | NMPA - National Medical Products Administration (formerly CFDA) |
| EHR - Electronic Health Record | OQ - Operational Qualification |
| EMA - European Medicines Agency | OTC - Over-the-Counter |
| EMR - Electronic Medical Record | PACS - Picture Archiving and Communication System |
| EN - European Norm | PMA - Pre-market Approval |
| ERP - Enterprise Resource Planning | PPE - Personal Protective Equipment |
| EUDAMED - European Database on Medical Devices | PQ - Performance Qualification |
| EudraLex - Collection of rules and regulations governing medicinal products in the European Union. | QA - Quality Assurance |
| EUDRAVIGILANCE - European Pharmacovigilance Database | QC - Quality Control |
| FDA - Food and Drug Administration | QMS - Quality Management System |
| FMEA - Failure Modes and Effects Analysis | QSR - Quality System Regulation |
| GDP - Good Distribution Practice | RFID - Radio Frequency Identification |
| GMP - Good Manufacturing Practice | SOP - Standard Operating Procedure |
| GSPR - General Safety and Performance Requirements | UDI - Unique Device Identification |
| HACCP - Hazard Analysis and Critical Control Points | V&V - Verification and Validation |
For questions on developing a MedTech test solution, please contact Averna.
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