You’re cautious and risk-averse because you need to worry about things like 21 CFR Part 820 and Part 11. You need to dot your i’s and cross your t’s.
Our expertise in the medical device industry focuses on test system development.
How we can help: our capabilities & expertise
Familiar with 21 CFR Part 820 and Part 11
Support V&V effort during IQ & OQ
Interface to Part 11 compliant databases for testing procedures and measurement results
- User access management
Test sequence release management
Deep expertise with PXI-based system development – Over 1,500 PXI projects completed, across multiple industries
Verification of test sequence content & content of test results
- Test report creation and management
Want more proof points? Check out these medical device test case studies:
Our client already had a test system in place, but the tester (really two test systems testing two different product variants) was becoming obsolete. The tester was old, hardware was failing, and it was getting harder and harder to keep it reliably running. They wanted a new tester to improve reliability, but maintain the functionality of the existing tester to keep the FDA-mandated verification and validation time to a minimum.
The updated end-of-line manufacturing test system maintains the functionality of the old test systems, but with updated hardware and software. The same software is utilized for both the manual test system update and the automated test system update. Our client deployed 6 manual testers and 1 automated tester.
- Improved maintainability and reliability with updated hardware and software
- Maintains existing test system functionality to keep certification time down
There were two variants of the new test system. One was for an older product line that utilized manual test, with an operator that connected/disconnected the UUT, and initiated the test. The other was an automated tester, integrated into a manufacturing machine. Both testers utilized custom fixtures (provided by the client), off-the-shelf NI measurement hardware (selected by Viewpoint), and custom test software (developed by Viewpoint). The software is configurable for both the manual test system and the automated test system.
|Read UUT limits from config file|
|Perform tester self-test|
|Measure UUT output|
|Perform leak down pressure test|
|PLC interface (for automated tester) for start, done, pass, fail|
*- images are conceptual, not actual
|LabVIEW RT – for managing the microcontroller functions and overall data collection and safety monitoring|
|Microcontroller application – to provide precision pulsing of the batteries|
|Communicate to the host PC – to both receive pulsing instructions and configurations and to return pulse waveforms for each battery tested.|
|MAIN HARDWARE COMPONENTS|
|PXI chassis & controller|
|PXI analog input modules|
|SCXI multiplexing switches|
|INTERFACES / PROTOCOLS:|