Table 1 Common QMS and Medical Device Terminology.

End-User Acceptance Testing

Testing that demonstrates that the product satisfies end-user defined requirements¹².

Corrective and Preventive Action (CAPA)

Changes to products and/or the quality management system to eliminate the cause of or prevent the occurrence of issues that affect the quality of products or processes⁹.

Design Controls

Interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances^8,12.

Design Verification and Validation

Testing or evaluation activities that provide objective evidence that the product satisfies its intended purpose (or use) and specifications⁹.

Installation Qualification

Testing or evaluation activities that demonstrate the software is installed correctly in its intended environment¹².

Intended Purpose (Intended Use)

The objective intent and general purpose of a product²⁹.

Operational Qualification

Testing or evaluation activities that demonstrate the software functions as intended¹².

Performance Qualification

Testing or evaluation activities that demonstrate the software satisfies user and business requirements¹².

Records

Documents or other artifacts that demonstrate that a process was completed⁸.

Software Development Life Cycle (SDLC)

A framework of processes, activities, and tasks phases to design, develop, and maintain software³⁰.

Monitoring and Surveillance

Tracking and analyzing the performance of and changes to products after deployment to identify quality or safety issues that may necessitate corrective or preventive action⁹.

Version Control

Activity related to software configuration management intended to track and manage changes to software. Version control is used during all stages of the software development life cycle to prevent mix-ups^8,30.