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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

 

 

 

 

 

Call: 978-509-1630

 

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