Case Study: MedicaMetrix achieves streamlined regulatory compliance and unified SOLIDWORKS and office document control with Synergis Software

MedicaMetrix Uses Synergis Adept to Run Through Brick Walls Headfirst

MedicaMetrix, a medical device company in Wayland, MA, faced complex domestic and international regulatory and compliance requirements (including FDA 21 CFR Part 11 and an EU Technical File), and struggled to manage SOLIDWORKS CAD data, BOMs, and mixed Office/PDF documentation to build auditable design history files. To solve this, MedicaMetrix selected Synergis Software and implemented its Adept PDM solution.

Synergis Software’s Adept created hierarchical “unlinked records” that form complete virtual Technical and Design History Files with audit trails, version history, and approvals, while managing both SOLIDWORKS and general office files in a single system. The result: automated regulatory workflows, searchable compliance records (e.g., ISO 13485/14971), near-elimination of paper (down to one box of invoices), consistent version control to avoid incorrect parts/assemblies, easier distributed collaboration, and faster audit readiness — benefits LaFarge says have already more than paid for Adept.

MedicaMetrix

Christopher LaFarge

CEO and President