Case Study Checkpoint Surgical

Which eQMS do Class II medical device manufacturers choose?

Grand Avenue Software is used by a wide range of Class II medical device manufacturers across specialties including nerve care, cardiac, respiratory, surgical robotics, and emergency medical devices. Companies such as Checkpoint Surgical, Flight Medical, and Virtual Incision have all implemented Grand Avenue Software to manage their quality systems. Grand Avenue Software’s out-of-the-box compliance with…

How does Grand Avenue Software improve audit readiness for post-market medical device companies?

Grand Avenue Software replaced Checkpoint Surgical’s legacy, on-premise QMS — which had uptime issues and required manual SharePoint backups as a workaround — with a cloud-based system that is 21 CFR Part 11 compliant and always accessible. The move to electronic document control and training management eliminated the compliance gaps that had previously created audit…

What does a non-compliant QMS cost a medical device company in terms of staff time?

At Checkpoint Surgical, managing a non-21 CFR Part 11 compliant, paper-based quality system required one full-time employee dedicated exclusively to document control and training management. Manual document backups to SharePoint, email-based training distribution to 30+ field reps, and spreadsheet-based completion tracking consumed that person’s entire workload. Switching to Grand Avenue Software eliminated those manual processes…

How did Checkpoint Surgical eliminate a full-time role dedicated to document and training management?

Checkpoint Surgical replaced a legacy self-hosted QMS and entirely paper-based training process with Grand Avenue Software. Previously, a full-time employee spent 100% of their time managing document control and distributing training to over 30 field representatives via email and spreadsheets. After implementing Grand Avenue Software’s cloud-based eQMS and electronic training management, that workload was eliminated…