ERP SOFTWARE SELECTION FOR MEDICAL DEVICES
Select ERP that connects design, regulated production, traceability, quality, service, and post-market visibility.
Medical device ERP selection has to account for the full device lifecycle, from design history and engineering handoff through manufacturing, quality, UDI, distribution, service, and field performance. The wrong platform can create workarounds where control and traceability matter most.
John Hannan LLC helps medical device companies run a vendor-neutral ERP Software Selection process that tests how vendors support design history, DMRs, supply chain, CMOs, CPOs, UDI and traceability, quality, CAPA, revenue recognition, FDA expectations, and global regulatory needs.
How We Help Medical Device Teams Select ERP
We bring industrial-engineering roots and deep med-device experience to ERP selections that span design, manufacturing, logistics, and post-market surveillance.
Map the device lifecycle into ERP requirements
We define what ERP must support across item masters, BOMs, routings, engineering changes, production, inspection, release, distribution, service, returns, and field inventory.
Evaluate traceability and quality controls in context
Vendors are asked to prove how they support lot and serial control, UDI, quality events, NC and CAPA handoffs, audit trails, controlled documentation, labeling, and recall visibility across the device lifecycle.
Address internal and outsourced operations
Selection criteria include how ERP supports internal manufacturing, CMOs, CPOs, suppliers, 3PLs, service depots, and field teams. We help clarify where ERP should own the process and where integrations are required.
Move from software decision to validated execution
We build RFPs, demos, scorecards, cost comparisons, and implementation guardrails with validation, testing, data, training, and go-live readiness in mind. The result is a selection process that supports both compliance and daily operations.
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
