Third time's the charm for a Class III medical device manufacturer
TriMed is a California-based medical device manufacturer.
Their upper and lower extremity orthopaedic implants help patients recover from musculoskeletal damage.
As a Class III medical device provider, TriMed works to the regulatory requirements of:
FDA 21 CFR 820
ISO 13485
MDSAP
MDD CE marking
TriMed went through two previous quality management set-ups:
1) A paper-based system
2) A competitor eQMS
With the paper-based system creaking as TriMed grew, and their replacement eQMS too inflexible to be configured, Quality Assurance Director Michael Holcomb began to search for a third quality management system option.
Once you have more than 10 people, paper-based just doesn't work.
There was widespread frustration with our replacement eQMS.
It was crucial that Mike worked with an eQMS vendor who could perform the bulk of the computerized system validation activity for TriMed.
Mike and the team used a hands-on approach of demos and vendor calls to pinpoint the best system, before the 'lightbulb' moment happened with Qualio:
I realized, 'oh my God, this is fantastic!'
We could configure Qualio within its validated state almost unlimitedly.
With Qualio's high levels of customization, TriMed knew they'd found the perfect eQMS and became Qualio customers in November 2021.
Qualio's white glove onboarding and validation service meant TriMed were live and ready to use their system by early December.
The contrast between Qualio and TriMed's previous eQMS was instantly clear.
Qualio could be easily configured and adapted to match and optimize TriMed's quality processes.
System engagement, training completion and customer feedback cycle time speed were drastically boosted.
And Mike enjoys total visibility of TriMed's quality landscape from within Qualio, allowing all activity to be reviewed and controlled from a single source.
Mike particularly enjoys:
Qualio's search functionality and the ability to locate all documents with a particular keyword in seconds
The ability to add comments to system activity
The 'limitless configuration' of Qualio
After two previous attempts, TriMed have found an eQMS which works with their processes, rather than having to shoehorn processes into an inflexible quality system.
