Page 259 - Safety Risk Management for Medical Devices

238 Appendix A: Glossary

Legacy Device Medical device which was legally placed on the market and is still marketed today but for
which there is insufficient objective evidence that it is in compliance with the current version of ISO 14971
Legacy software MEDICAL DEVICE SOFTWARE which was legally placed on the market and is
still marketed today but for which there is insufficient objective evidence that it was developed in
compliance with the current version of this standard [9]
MDD Medical Device Directive
MDR Medical Device Reporting—Mandatory reporting requirement to the FDA
ME Medical Electrical equipment/systems
MedTech Medical Technology
NBRG Notified Bodies Recommendation Group
OR Operating Room
PFD Process Flow Diagram
PFMEA Process Failure Modes and Effects Analysis
PHA Preliminary Hazard Analysis
QC Quality Control
QMS Quality Management System
R&D Research and Development team/organization
RACT Risk Assessment and Control Table
RC Risk Control
RM Risk Management
RMF Risk Management File
RMT Risk Management Team
RPN Risk Priority Number
SADE Serious Adverse Device Effect
SAE Serious Adverse Event
SFMEA Software Failure Modes and Effects Analysis
SME Subject Matter Expert
Software defect An error in design/implementation of the software
Software failure A software condition that causes the System not to perform according to its
specification
Software fault A software condition that causes the software not to perform as intended
Software Item Any identifiable part of a computer program, i.e., source code, object code, control
code, control data, or a collection of these items [9]
Software System Integrated collection of Software Items organized to accomplish a specific function
or set of functions [9]
Software Unit Software Item that is not subdivided into other items [9]
SOP Standard Operating Procedure
SOTA State of the Art
SOUP Software of Unknown Provenance
Standard of Care The level at which the average, prudent clinical care provider would practice
SW Software
TBD To Be Determined
UI User Interface
UMFMEA Use-Misuse Failure Modes and Effects Analysis
USA United States of America
Use Error User action or lack of user action while using the medical device that leads to a different
result than that intended by the manufacturer or expected by the user [14]
VF Ventricular Fibrillation