Medical Device & Medical Supplies Traceability Solutions for UDI Labeling, Device History, and Fast, Narrow Recalls
When a device or supply lot needs to be recalled, the difference between pulling ten units and ten thousand comes down to how tightly your traceability record is built. KnarrTek's medical traceability solutions — BellHawk and MilramX — give medical device and medical supply manufacturers and distributors real-time lot and serial tracking, UDI-compliant labeling, and an audit-ready Device History Record for every unit — so a recall stays as narrow as the problem that caused it.
What KnarrTek actually does for medical device and supply operations
BellHawk and MilramX, KnarrTek's medical traceability solutions, aren't paperwork you assemble after the fact when an auditor or a complaint shows up. They're the system that captures lot, serial, and component data the moment it moves, so a Device History Record is already built by the time anyone asks for it.
Real-Time Lot & Serial Tracking
Barcode and RFID scans update component, lot, and device status the moment they move, so what's in the system matches what's actually on the line.
UDI-Compliant Labeling
Unique Device Identification labels are generated automatically from the same record that tracks the device, so the label always matches the history behind it.
Audit-Ready Device History Records
Every scan writes to the record automatically, so a DHR is assembled as work happens instead of reconstructed the week before an audit.
Narrow, Fast Recalls
One-step-forward and one-step-back traceability lets you identify exactly which units are affected, instead of pulling an entire lot to be safe.
The traceability gaps medical device and supply operations deal with today
These challenges show up across device manufacturers, medical supply distributors, and multi-site operations alike — and they're the ones KnarrTek's platforms are built to close.
Recall Scope You Can't Control
Without lot- and serial-level traceability, a single defect can force a recall of an entire production run instead of the units actually affected.
Manual Device History Records
Assembling a DHR by hand from paper travelers and separate spreadsheets eats staff time and leaves gaps that are hard to explain during an inspection.
Fragmented Systems & Manual Records
When the ERP, quality system, and paper logs don't talk to each other, staff spend real time reconciling records instead of moving product through the line.
Rising Operational Costs
Manual data entry, rework from transcription errors, and duplicate systems all add hidden cost that's hard to see until it's added up over a year.
What BellHawk does for medical device and supply operations
BellHawk is a Manufacturing Execution System (MES) and Warehouse Management System (WMS) built for medical device and medical supply manufacturers and distributors, replacing paper forms and manual data entry with barcode scanning and mobile devices so every lot, component, and finished device is tracked in real time.
Materials & Lot Tracking
Monitor components and finished devices by lot and serial number, storage location, expiration date, and quality status across every site.
One-Step Traceability
Capture data on the components used in every device, enabling instant forward and backward traceability to pinpoint defect origins and narrow recall scope.
Quality Assurance
Document every production step, including quality checks and test results, to support GMP-aligned quality standards and internal requirements.
UDI Label Automation
Generate UDI- and GS1-compliant barcode labels tailored to specific products and customers, keeping labels accurate and consistent with the record.
Operational Visibility
Real-time insight into inventory, production progress, equipment usage, labor, and order fulfillment across every site.
From component receiving to the Device History Record, in real time
Components, lots, and finished devices are scanned by barcode and RFID at receiving, assembly, sterilization, and shipping into the BellHawk engine as work happens. BellHawk records lot, serial, and location data, tracks quality checks and sterilization cycles across every workflow, and generates UDI-compliant labels at each step. That record feeds the data MilramX uses to trigger rules-based alerts on quality holds or delays, assemble the audit-ready Device History Record, and synchronize selected data with ERP and other business systems.
- Barcode and RFID capture at receiving, assembly, sterilization, and shipping.
- Real-time lot and serial status tracked across every site.
- One-step traceability linking every component to every finished device.
- Rules-based alerts flag quality holds, delays, or missed process steps.
- Offline store-and-forward capture keeps line staff moving without a live connection.
- Selected data synchronized to ERP and other systems via MilramX.
What happens to a device as it moves through production
Each of these stages is a real sequence a BellHawk-enabled operation follows, and each one writes something to the record — so a Device History Record builds itself, recalls stay narrow, and downstream systems stay current automatically instead of by hand.
Receive & Track
Components and materials are scanned on arrival and allocated to a lot or work order, with source, quantity, and location recorded.
Assemble & Sterilize
Assembly and sterilization steps are validated in real time, with operator, equipment, and cycle data captured at every step.
Label & Report
UDI labels and the Device History Record are generated at completion, and results sync to ERP and other systems for seamless reporting.
Device History Records and UDI labeling, built as work happens
A Device History Record is only useful if it's complete and it's fast to pull. BellHawk assembles the DHR automatically as components are received, assembled, sterilized, and labeled — and links it directly to any complaint or adverse-event record, so the full history of a device is one lookup away, not a week of digging through paper travelers.
UDI Label Generation
Unique Device Identification labels are generated directly from the production record, so the label on the box always matches the history behind it.
Device History Record Assembly
Every receipt, build step, sterilization cycle, and quality check writes into the same record, assembling the DHR automatically instead of by hand.
Complaint & Adverse-Event Linkage
A complaint or adverse-event record links directly back to the specific lot and components involved, so investigations start with the record instead of a search.
Deployment flexibility for medical device and supply environments
KnarrTek's platforms adapt to how and where operations actually run, supporting minimal disruption during implementation and long-term scalability as your site count and production volume grow.
Browser-Based Access
Cloud-hosted tracking for inventory, lots, and production status, visible the moment they're scanned, with no local server to maintain.
Rugged Mobile & Offline Capture
Mobile devices capture barcode and RFID scans on the line even with limited connectivity, synchronizing automatically once a connection is restored.
Multi-Site Networks
Data capture stays local at each site while centralized dashboards give leadership real-time visibility across every location.
Where MilramX extends BellHawk with automation
MilramX is the half of KnarrTek's medical device solutions that turns BellHawk's real-time scan data into action — automating workflows and synchronizing information across ERP and other systems, so quality and operations teams see problems as they happen instead of at the next status meeting.
Smart Automation
An intelligent-agent framework manages parallel tasks like data transfers and notifications, streamlining operations without constant manual oversight.
Data Integration
Collects and processes data from multiple systems into High Level Data Objects (HLDOs), simplifying management and keeping every report consistent.
Operations Dashboard
Monitors purchase orders, work orders, move orders, and shipments in real time for enhanced oversight across the operation.
Error Management
Automated error detection and correction supports continuous operation, with alerts for IT support when something needs a human look.
Adaptable Integration
Connects with ERP, CRM, and other systems, adapting to diverse medical device and medical supply applications as your requirements change.
Why medical device and supply operations choose KnarrTek
KnarrTek's medical traceability solutions tackle the problems actually costing operations time, money, and recall exposure: manual Device History Records, fragmented systems, and rework from avoidable errors.
Rapid, Narrow Traceability
Instant one-step-backward and one-step-forward tracking pinpoints exactly which lots and units are affected, minimizing recall scope.
Cost Savings
Operations commonly report meaningful savings within the first year from labor reduction, fewer errors, and less waste, with results varying by operation size.
Enhanced Safety
Tracking materials, personnel, and process steps together helps mitigate risk and supports consumer safety and quality-standard compliance.
Operational Efficiency
Real-time visibility and automation reduce manual processes and improve inventory, production, and quality management together.
Scalability
Tailored for small to mid-sized organizations and multi-site operations alike, with configurations that fit your specific product lines.
Audit-Ready Documentation
Device History Records and UDI labeling documentation are assembled automatically, ready the moment an inspector or auditor asks for them.
Two ways medical device traceability solutions are deployed
BellHawk and MilramX support a range of deployment shapes. These are representative patterns rather than a specific operation's results, described so you can recognize which one resembles your own.
One-step traceability and UDI compliance tied to a single production record
Every lot gets built, sterilized, and labeled against the same record — no separate spreadsheet tracking which units are already labeled.
A single-site device manufacturer deploys BellHawk to log components at receiving, track assembly and sterilization in real time, and generate UDI labels and Device History Records automatically. MilramX synchronizes results with the operation's ERP, so quality holds and releases stay consistent no matter who's reviewing them.
Faster DHR assembly, narrower recall scope if one is ever needed, and less manual reconciliation between the line and quality.
Consistent labeling and traceability across every facility
One dashboard shows quality leadership what's happening at every site, instead of waiting on a status call from each plant manager.
A multi-site manufacturer or distributor deploys BellHawk at each location to capture receiving, assembly, and shipping activity, with mobile devices supporting offline capture where connectivity is limited. MilramX consolidates lot status, inventory, and quality data across sites into dashboards for leadership, without requiring every site to run on the same network.
One consolidated view across sites, faster identification of which location needs support, and consistent UDI labeling wherever product ships from.
These are representative application patterns, not guaranteed outcomes. Actual results depend on operation scope, production volume, network availability, process design, implementation scope, data quality, integrations, procedures, training, and user adoption.
Three ways to run medical device traceability software
BellHawk and MilramX are the medical device traceability software underneath KnarrTek's product line, delivered as three packaged options. Which one fits depends on how much of your operation runs through the system, how you need to deploy it, and how much automation you want around exceptions.
BellHawk Online
Browser-based real-time tracking for inventory, lots, barcode scans, and production activity, without replacing your ERP platform. Receipts, job status, and shipments are visible the moment they're scanned, with no local server to maintain.
WIPtracker
In-facility WMS control covering receiving, assembly, sterilization, and secondary operations, plus barcode and RFID data capture — the deeper on-site foundation manufacturers use for full traceability control.
SmartOps24x7
ERP integration and smart operations monitoring built around KnarrTek's MilramX agents, adding rules-based alerts, continuous system oversight, and automated data exchange across connected systems and sites.
Medical device tracking is one part of a larger record
BellHawk's medical device traceability software works alongside the other ways KnarrTek collects data at the point of work. Most deployments combine two or three of these.
Inventory & Asset Tracking
Accurately track inventory and assets with barcode and RFID tracking, the record that every transaction posts into.
Inventory trackingRFID Inventory System
Streamline real-time inventory tracking with barcode and RFID technology where scanning alone is impractical.
RFID trackingReal-Time WIP Tracking
Real-time visibility into work-in-process across all sites, so a device's status is always current wherever it sits.
WIP trackingMaterials Flow & Job Tracking
Monitor material flow and job progress with real-time inventory tracking for efficient operations.
Job trackingKnarrTek has solutions built around more specific requirements too
This page covers medical devices and medical supplies specifically — UDI labeling, Device History Records, and device-focused quality standards. If your operation fits one of these more specific descriptions, these pages go deeper on exactly that.
Prescription Drug Manufacturing
DSCSA serialization, CFR 21 Part 11, and GMP compliance built specifically for pharmaceutical manufacturers and distributors.
Pharmaceutical management solutionsGeneral Laboratory Testing
Sample intake, cold-chain tracking, and chain-of-custody built for analytical, QC, clinical, and environmental testing labs.
Laboratory traceability solutionsBiotech Manufacturing
Traceability built around biotech-specific production, materials, and regulatory requirements.
Biotech traceability solutionsCommon questions about running an operation on KnarrTek
Practical answers about KnarrTek's medical device traceability solutions — BellHawk, MilramX, and what actually changes on the line once an operation starts using them.
Does this cover DSCSA or drug serialization requirements?
Is this different from KnarrTek's Pharmaceutical Management Solutions page?
What if I only run a single site?
How does UDI labeling actually work?
Does this support FDA Quality System Regulation compliance?
Does BellHawk work on the line without a live connection?
Can this integrate with our ERP or quality system?
What deployment options are available?
What's the difference between BellHawk and MilramX?
How does this help if a recall does happen?
Do we have to choose between barcode and RFID?
Can this scale from a single facility to multiple sites?
Turn manual Device History Records into a system that builds them for you
Start with the gap causing you the most exposure — UDI labeling, Device History Record assembly, or system integration. KnarrTek's medical traceability solutions team can help map what to track first and how to deploy it, on-premise, in the cloud, or across multiple sites.
