ERP ADVISORY & SOFTWARE SELECTIN FOR MEDICAL DEVICES
Create a digital thread in ERP so every device is controlled, traceable, and service-ready from day one.
We help medical device companies select and implement ERP that supports design history and DMRs, supply chain and CMOs and CPOs, UDI and traceability, quality and CAPA, and revenue standards like ASC 606, while meeting FDA and global regulatory expectations.
How We Help Medical Device Manufacturers
We bring industrial-engineering roots and deep med-device experience to ERP selections that span design, manufacturing, logistics, and post-market surveillance.
Tie engineering and design control into ERP from the start
We map how design control, DHFs, DMRs, and engineering change orders should interact with ERP item masters, BOMs, and routings. Vendors are asked to show how controlled documents, revisions, and approvals flow into production and service, so design intent survives beyond the Product Lifecycle Management (PLM) system.
Support regulated production, QMS, and device traceability
We define requirements for Quality Management System (QMS) integration, NC and CAPA handling, in-process inspection, lot and serial control, Unique Device Identification (UDI), and labeling. Demo scenarios walk through component receipt → inspection/quarantine → build → device release → field traceability, including how ERP supports investigations and recalls across geographies and channels.
Design ERP around outsourced manufacturing and global logistics
We capture how your CMOs and CPOs operate, how inventory moves through 3PLs and regional warehouses, and how service depots and field technicians interact with devices in the field. That informs selection criteria for supply-chain visibility, drop-ship and consignment models, RMA/returns, and integration to service/field systems.
Choose and validate ERP for the full device lifecycle
We create med-device-specific RFPs and scorecards that emphasize 21 CFR Part 11/820 alignment, audit trails, document control, QMS and LIMS connections, revenue recognition, and partner depth in medical devices. We then support CSV planning, IQ, OQ, and PQ, and implementation governance so ERP becomes the backbone for compliant, scalable device operations, not another system to work around.
Why Medical Device Manufacturers Choose Us
OPERATIONS FIRST MINDSET
We speak plant, not just platform
EXPANSIVE KNOWLEDGE
Knowledge of 40+ ERP vendors so you're matched with the right fit
EXPERIENCED LEADERSHIP
Engagement led by long-tenured leader from first conversation through go-live
ACTIONABLE, READY-TO-USE DELIVERABLES
Designed for your business but structured to plug into your project
Making Medical Device Companies' Vision a Reality
The following are medical devices topic excerpts from our ERP Visions blog
