About MESvantage
MESvantage is the manufacturing intelligence platform purpose-built for medical device contract manufacturers.
Generic MES platforms require months of configuration. Compliance-only systems are QMS tools masquerading as MES. Enterprise platforms are priced for Fortune 500 OEMs, not contract manufacturers. None of them were designed for a high-volume regulated CDMO from the first line of code.
MESvantage was developed inside a live high-volume orthopaedic production environment — validated under FDA 21 CFR Part 11, certified under ISO 13485, and stress-tested against real shop-floor conditions before it ever reached a customer.
It is the system every CDMO operations director wishes they had bought five years ago — and the one they can deploy in 90 days, not five.
Built for CDMOs
DHR, FAI, CMM, OEE, genealogy, customer quality portals — every workflow designed for medical device contract manufacturing from day one.
Already validated
IQ/OQ/PQ baseline passed in a live regulated environment. Validation documentation transfers with the platform — not a 12-month programme.
Production-grade
Stress-tested at scale, 24/7, under FDA scrutiny. Every feature has run on a real production floor before it ships.
Get in touch
Book a demo, ask a compliance question, or tell us about your environment. We respond within one business day.