|Overview: Regulations, Standards, Guidelines
||Learn about the various regulations, such as 21 CFR parts 820 and 11, that govern the creation of systems to test medical devices. This section also reviews standards, such as ISO 13485 and ISO 14971, that provide mechanisms and processes to meet quality and risk management regulations. Finally, explore the Good Automated Manufacturing Process (GAMP) guideline and its role in medical device test.
||Examine the considerations for medical device test equipment creation including decisions about how, where, and what to test. This section also describes the difference between design validation and manufacturing test, the various sources of requirements for a test system, and the association between device hazards and test system requirements.
||Explore the processes that apply across the entire medical device development life cycle. This section includes overviews of risk management, requirement traceability, configuration management, and change control. In addition, discover the association between the life cycle of the medical device and the life cycle of associated test equipment.
|Test Equipment Life-Cycle Activities
||Learn about the activities necessary to create test equipment for a medical device. This section includes detailed suggestions on requirement creation and tracking, risk management for test equipment, development practices, verification, and validation activities, Requirements Gateway, LabVIEW Unit Test Framework Toolkit, and LabVIEW VI Analyzer Toolkit. In addition, it features information specific to LabVIEW on development practices, testing, documentation, and traceability.
||Discuss the ongoing maintenance of medical device test equipment in use. This section includes information on the control of software and security on test equipment, the process of making changes, and the role of risk management in alterations to the system. This section also analyzes the challenges associated with maintaining equipment that uses commercial off-the-shelf (COTS) hardware and software and provides suggestions for managing these challenges.
||Examine the process of withdrawing and decommissioning test equipment and the importance of planning for retirement early in the system life cycle.