Technician in a hairnet and gloves scanning packaged medical device trays

Lot Traced. Signature Logged. Audit-Ready.

21 CFR Part 11 audit trails, electronic signatures, lot traceability, and quality management, set up for how regulated manufacturers actually run.

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Industries/NetSuite for Medical Device

Every Lot Traced and Signature Logged. Audit-Ready by Design.

We have configured NetSuite for FDA-regulated device makers like Inari and Aurora Spine: 21 CFR Part 11 audit trails, electronic signatures, lot traceability, and quality management.

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OUR APPROACH

Compliance isn't a module you add. It's how the system gets configured.

Part 11 controls, lot genealogy, quality records, and contract-manufacturing visibility are decisions made in the first week of configuration, not patched in before an audit. Here's how each one gets built.

PART 11
Configured like general manufacturing.
Audit trails are incomplete and electronic signatures aren't enforced, so gaps surface when the FDA does.
How We Solve It
Role-based access, enforced e-signature workflows, and audit trails on every transaction, set up for 21 CFR Part 11 from the first week.
TRACEABILITY
A mock recall still needs spreadsheets.
Tracing a lot from raw material to customer delivery takes days of manual cross-referencing, not hours.
How We Solve It
Lot genealogy runs upstream and downstream with UDI support in inventory, so a mock recall finishes in under an hour.
QUALITY
Quality lives beside production, not inside it.
Non-conformances sit in spreadsheets, unlinked from the production records they came from.
How We Solve It
Inspection plans sit inside the work order at receiving, in-process, and final, with CAPA escalation triggered automatically.
OUTSOURCING
Contract manufacturing is a black box.
Half of production happens outside your walls, managed over email with no live view of WIP or quality.
How We Solve It
External production is managed like in-house — real-time WIP, vendor location management, DRP, and their quality data in your dashboard.

Compliance first. Everything else follows.

We've configured NetSuite for FDA-regulated device makers like Inari and Aurora Spine. Part 11 audit trails, electronic signatures, lot traceability, and quality management are scoped before the first build sprint, not bolted on before an audit.

Talk to Our MedTech Specialist

A 30-minute review of your compliance requirements. No pitch.

01 / 02

Our team was spending more time working outside our ERP and using Excel to manage day to day work. The usability just wasn't there with QAD. In a fast-paced industry, accuracy and visibility are key. We need to be able to trust our data to quickly make decisions.

Chad Clouse

CFO · Aurora Spine

CUSTOMER STORIES

Proof From Regulated Floors

Not one-off go-lives. These regulated manufacturers have run on NetSuite with Luxent for years. What changed, and why they stayed.

All customer stories

Exterior of the Inari Medical headquarters building

Medical Device

Inari Medical

How Inari Medical traded patchwork systems for an ERP that could grow as fast as it did

130+

employees onboarded mid-ramp

Aurora Spine interbody implant seated between vertebrae

Medical Device

Aurora Spine

How a publicly traded spinal implant maker traded QAD and Excel for real-time visibility on NetSuite

Real-time

assets tracked from supply chain to OR

Technicians in cleanroom suits working in a sterile production area — SHINE Medical

Medical Device

SHINE Medical

How SHINE traded a rigid legacy system for a cloud platform that keeps pace with fusion

5 mo

to an FDA-validated go-live

Where NetSuite Fits

A stronger operating environment for medical device companies

Stay audit-ready by default
Quality Management runs inspections at receiving, in-process, and final. Results are captured automatically, non-conformances tracked through CAPA to resolution. The documentation happens as the work happens. No one needs to remember to write it down.
Financials auditors won't question
Keep books that hold up to the same scrutiny as your quality system. NetSuite's Financial Management module handles consolidated billing, budgeting, and reporting to the standard auditors expect, with multi-subsidiary and multi-currency support and a faster close.
Control the parts you don't own
Your suppliers are part of your quality system whether you can see them or not. Supply Chain & Procurement qualifies and scores vendors, runs RFQs, POs, and contracts, and pulls contract-manufacturing oversight into your planning.
Balance capacity, hold every checkpoint
Hit demand without letting a single quality gate slip. Planning & Scheduling runs demand-driven MRP with finite and infinite capacity scheduling on a drag-and-drop Gantt, keeping the floor balanced and every checkpoint in place.
Digitize every manufacturing step
Capture what happened on the line as it happens, not on paper afterward. NetSuite's Shop Floor Control module puts real-time data capture and per-work-center queues on a tablet, recording the when, where, what, why, and how of every step.
Trace every lot in seconds
When a recall question lands, the answer is one screen away. Inventory Management tracks every lot with full traceability and multi-location visibility, and manages shelf life and replenishment for sterile or dated stock.

YOUR NEXT STEP

Let's review your compliance requirements before you commit.

Talk to Our MedTech Team

17+ Years NetSuite Delivery
NetSuite Certified Solution Partner
No Pressure First Call

From the Luxent blog

NetSuite Medical Device Insights

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ASKED & ANSWERED

Before You Choose a Medical Device NetSuite Partner

Yes. NetSuite provides electronic signatures, comprehensive audit trails, role-based access controls, and version tracking. NetSuite provides the tools; Luxent configures them correctly for your specific regulatory environment, with SuiteSuccess Healthcare Edition available for HIPAA compliance where needed.

You get full upstream and downstream lot tracking from raw-material receipt through customer delivery, plus recall management that identifies every affected lot and every customer who received it. Our configuration standard is a mock recall you can run in under an hour.

Yes. You get real-time visibility into external production, vendor-location management, and DRP for multi-site planning. Your contract manufacturer's output appears in your dashboard as if it were your own floor.

Inspection plans run at receiving, in-process, and final stages with pass/fail criteria, non-conformance tracking, and a CAPA workflow. Quality management lives inside production — not in a separate spreadsheet.

Yes. You get lot-tracked inventory, multi-location visibility, shelf-life management, and automated replenishment. Every lot number, every location, and every expiration date in one real-time view.

Pricing depends on module count, user count, and compliance requirements, and it tends to run higher than general manufacturing because of the quality-management and regulatory modules. We'll scope your specific requirements in the first conversation — not hand you a range that spans $400K.

Typically 3 to 9 months, depending on complexity, contract-manufacturing oversight, integration count, and validation requirements. Medical device implementations take longer than general manufacturing because compliance validation adds steps — we build that into the timeline from day one.

Compliance gaps in a live system are urgent. We audit your current configuration, identify the gaps, and build a remediation plan to bring it into line — without starting over from scratch.

When we saw how easily the system could be tailored and react on the fly, we knew the NetSuite-Luxent partnership was exactly what we were looking for.

Norman NieDirector of IT Ops · Inari Medical

Lot Traced. Signature Logged. Audit-Ready.

Compliance isn't a module you add. It's how the system gets configured.

Configured like general manufacturing.

A mock recall still needs spreadsheets.

Quality lives beside production, not inside it.

Contract manufacturing is a black box.

Compliance first. Everything else follows.