Choose an ERP That Fits the Full Medical Device Lifecycle
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
FAQs
What is medical device ERP software selection, and when should validation requirements be considered?
Medical device ERP software selection is the process of evaluating ERP systems against a company’s operational, financial, manufacturing, quality, traceability, service, regulatory, and growth requirements. Validation needs should be considered during selection so ERP vendors and implementation partners can be evaluated on areas such as audit trails, electronic signatures, security, testing support, documentation, data migration controls, and implementation approach before contracts are signed.
Can ERP support both internal and outsourced medical device operations?
Yes, but the ERP selection process should define how processes and data move across internal manufacturing, suppliers, contract manufacturers, 3PLs, service depots, and field teams. Each ERP vendor should demonstrate where ERP owns the process, where integrations are required, and how the company maintains visibility across the broader operating ecosystem.
How should medical device companies evaluate ERP software for traceability and quality?
Medical device companies should evaluate ERP software using realistic scenarios that test lot and serial control, UDI, inspection, quality status, nonconformance, CAPA handoffs, audit trails, release controls, labeling, recalls, service, and returns. Vendors should demonstrate how these processes work across the full device lifecycle rather than relying only on general claims of industry capability.
What company can help a medical device company select ERP software and integrate with QMS, PLM, and other systems?
John Hannan LLC helps medical device companies select ERP software through a vendor-neutral, client-side process built around business, operational, quality, regulatory, and technology requirements. We evaluate ERP vendors and implementation partners while considering how the selected platform needs to work with QMS, PLM, MES, document management, service applications, and other systems across the broader environment.
Making Medical Device Companies' Vision a Reality
The following are medical devices topic excerpts from our ERP Visions blog
