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Common Terminology

Risk Management

A continuous process for systematically identifying, analyzing, treating, and monitoring risk throughout the life cycle of a product or service.


Configuration Management/Control

The process of systematically controlling and managing the documentation, software, and hardware which makes up the product.  


Common Medical Device Acronyms

CSA: Canadian Safety Association


„„CGMP:  Commonly refers to the Food and Drug Administration (FDA) 's regulations regarding Current Good Manufacturing Practices.  These Federal regulations are also referred to by their Title and Chapter: 21CFR820.


EN60601-1: European safety standards


EN13485: European medical device quality standard


ETL: Electrical Testing Laboratory; electrical product safety testing (like UL)


DHF:  Design History File.A compilation of design records which describes the design history of a finished device and/or product since its inception and continuing through release to production.


DHR/DMR: Design History Record/ Device Master Record.  A compilation of records containing the procedures and specifications for a finished device and/or product once it is in production or undergoing regulatory & clinical testing.


IDE:   Investigational Device Exemption


IEC:   International Electrotechnical Commission


ISO:   International Standards Organization


PMA: Premarket Application to the FDA


PMP: A Program Management Professional, certified by the Program Management Institute (PMI)


RoHS: The European Community directive for Restriction of Hazardous Substances.

Restricts the use of certain hazardous substances in electrical and electronic equipment


UL: Underwriters Safety Laboratories


WEEE: The European Community Waste Electrical and Electronic Equipment  

           Directive covering electrical and electronic equipment waste






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