Medical

Good manufacturing practices for test systems are no different than for the product itself. Both require proper design, implementation, and testing stages. Both must be developed under a process that is managed to assure compliance with GMP 21 CFR Part 820 rules. Viewpoint has the tools and experience to give you that assurance. Plus, we have created MedTest, a software architecture built on TestStand™ and LabVIEW™ and designed with medical device testing in mind.

Of course, each one of our client's products is different and custom test steps need to be developed. Typical steps are:

• Our engineers work with your team to review your device operation and test requirements.
• We design the test system to cover those requirements via a documented traceability matrix.
• We build our software test steps and hardware control and measurement subsystems to assure verifiable results.
• Calibration management is built into every system.
• Test sequence development and test step code are managed with our internal development process.
• Test results can be integrated into electronic databases and reports can be printed. Either way, we're ready for compliance with 21 CFR Part 11 rules when you are.

Many of these steps are simplified by using our MedTest architecture. More information about MedTest can be found here.