Case Study Intricon

How does Grand Avenue Software improve supplier management for medical device contract manufacturers?

Grand Avenue Software’s eQMS gave Intricon improved visibility and control over their approved supplier list (ASL) management, replacing the fragmented supplier processes that had previously limited oversight. With supplier data connected to the broader quality system, Intricon could manage supplier qualification and monitoring more efficiently and with a clearer audit trail.

Why does a medical device contract manufacturer need an eQMS even if they don’t make finished devices?

Contract manufacturers like Intricon must meet the same ISO 13485:2016 quality standards as the OEM customers whose devices they produce components for. Any compliance gaps at the contract manufacturer level can directly affect their customers’ regulatory standing. For Intricon, maintaining a fully compliant and auditable eQMS is a non-negotiable requirement for retaining and growing its…

How did Intricon replace paper-based NCMRs and CAPAs with a cloud-based eQMS?

Intricon, a contract manufacturer for medical device OEMs, migrated from paper-based and fragmented systems for NCMRs, CAPAs, and supplier management to Grand Avenue Software’s cloud-based eQMS using minimal customization and out-of-the-box functionality. The transition gave Intricon greater visibility into task status, easier document change request (DCR) workflows, and improved approved supplier list (ASL) management —…