Replacing NeuFit's manual QMS with Qualio bore fruit immediately.
The need to invest in additional headcount and consultancy was removed, saving NeuFit $130,000 in planned spend.
The visibility and control of an eQMS allowed Ami to spot and fix quality issues invisible in a paper system, resulting in a boost in customer satisfaction and allowing a failure part to be detected and fixed early.
Quality events are closed out more quickly, and the organization anticipates an accelerated route to market for their next medical device.
And best of all, the 6-day events of regulatory audits can now be completed in half a day.
After the disappointment of their previous FDA inspection, Ami is confident, happy and excited to show their new quality system off next time:
We're so streamlined now.
It's amazing where we were, compared to where we are now.
I hope we get the same auditor in future, so I can say, 'look how wonderful this is now!'