CTS gives medical device manufacturers an FDA-compliant leak/blockage test

FDA's 21 CFR Part 11 compliancy matters for many medical device manufacturers. Cincinnati Test Systems (CTS) has worked extensively with our customers in the medical device industry to identify what capabilities a leak/blockage test system must have to be compliant. 

The results have been distilled into our Sentinel Blackbelt Pro. It delivers the features and functionality medical device manufacturers need to ensure their leak test is compliant with 21 CFR Part 11 and EU Annex 11.

Learn more in this application note: "Making the grade with the FDA’s Title 21 CFR Part 11

Download (1 mb) CTS Blackbelt Pro: 21 CFR Part 11