Taught by experts in the medical device regulatory space and NI products, the LabVIEW in Regulated Markets Course helps learners navigate regulatory requirements and business demands when using LabVIEW for test and automation for medical devices. The course delivers best practices for design validation and manufacturing test using a fictional example of a medical device manufacturing test fixture throughout the course to illustrate concepts and provide a basis for discussion.
Instructor-led Classroom: Two (2) Days
Users developing medical device test systems (design validation, manufacturing test) or manufacturing automation with NI products
Experience with NI test system development
Some understanding of medical device test applications
LabVIEW Core 3 Course or experience developing medium to large LabVIEW applications
LabVIEW
Requirements Gateway
LabVIEW VI Analyzer Toolkit
LabVIEW Unit Test Framework Toolkit
Understand the regulatory requirements in this space
Implement best practices for using standards and application life-cycle processes
Use the GAMP5 risk-based process approach for developing test applications
Use NI tools and techniques to simplify testing and documentation requirements for your applications
| Lesson | Overview |
|---|---|
| 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. |
| Concept | 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. |
| Life-Cycle Processes | 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. |
| Operation Phase | 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. |
| Retirement Phase | Examine the process of withdrawing and decommissioning test equipment and the importance of planning for retirement early in the system life cycle. |