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. Your test system needs go beyond what other non-regulated industries are accustomed to. Specifically, you need to manage the development and delivery processes to assure that the test system covers all the test requirements and does exactly what it was designed to do. Build the right thing and build the thing right, as the saying goes.
These processes need to satisfy 21 CFR Part 820 and, nowadays, almost certainly Part 11 for any electronic records, including the software which the test system runs and any records it produces. We understand that the development of any test system we design and build for you would need to follow your IQ/OQ/PQ processes and we would work closely with your Quality Team.
We find sometimes that our clients need assistance in developing the test requirements documentation because that process often requires an understanding of the capabilities of test hardware. We can collaborate with you on that effort.
Bottom line: we understand the regulated environment you live in. Part 820 and Part 11 provide guidelines for good manufacturing processes, and we’ve been seeing these development and delivery concepts being adopted in other non-medical industries. Our clients are increasingly seeing the benefits of doing the right thing and doing the thing right, just like you (and we) have been doing for a long time.