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