Medical traceability solutions for UDI labeling, Device History Records, and fast, narrow recalls.

No. DSCSA applies to prescription drug supply chains, not medical devices. This page is built around the requirements that apply to devices and supplies: UDI labeling, Device History Records, and FDA's Quality Management System Regulation. If you manufacture or distribute prescription drugs, KnarrTek's Pharmaceutical Management Solutions page covers DSCSA and drug-specific recordkeeping directly.

Yes. This page covers KnarrTek's medical traceability solutions for devices and medical supplies, including UDI labeling and Device History Records. The Pharmaceutical Management Solutions page goes deeper on drug-specific requirements such as DSCSA serialization. Some organizations that handle both devices and drugs use both.

That works. Everything on this page applies to a single site from day one. BellHawk and MilramX deploy the same way whether you run one facility or coordinate several.

As part of KnarrTek’s medical traceability solutions, BellHawk generates UDI labels from the same record that tracks the device through production, so the printed lot, serial number, expiration date, and manufacture date match the history behind them. Label formats are configured with your team. Submitting device data to FDA's GUDID database is a separate step that stays with your regulatory team.

BellHawk's traceability and historical data capture support the documentation that a quality system needs. FDA's Quality Management System Regulation, the revised 21 CFR Part 820 effective February 2, 2026, is enforced through FDA inspection. The software supports your documentation; it does not certify a business or a product, and compliance responsibility remains with the customer.

Yes. Mobile devices support offline store-and-forward capture, so line staff can scan components, update status, and record results with limited connectivity. Captured data synchronizes automatically once a connection is restored.

Yes. MilramX synchronizes BellHawk's inventory, production, and quality data with ERP, CRM, and other business systems, reducing duplicate data entry and avoiding the cost and disruption of a full system replacement.

Three. Browser-based cloud access suits operations that want tracking without infrastructure, on-premise suits facilities that need full IT control, and multi-site configurations keep data capture local while centralized dashboards give leadership visibility across every location.

BellHawk captures barcode and RFID scan data on components, lots, and devices at receiving, assembly, sterilization, and shipping. MilramX sits on top of that data, adding rules-based automation, alerts, and integration with ERP and other systems. Most operations start with BellHawk for traceability control and add MilramX when they need automated cross-system coordination.

One-step-forward and one-step-back traceability means you can identify which lots, components, and finished devices are connected to a given issue, instead of pulling an entire production run to be safe. Decisions about holds and recalls stay with your quality and regulatory team; the software supplies the connected records.

No. BellHawk reads barcode and RFID data side by side, so an operation can use whichever capture method fits a given workflow, on the same line, without maintaining separate systems.

Yes. BellHawk and MilramX deploy the same way whether you run one facility or several. Multi-site configurations give leadership a consolidated view without a system overhaul as you grow.

A Device History Record, or DHR, is the production record for a device, lot, or batch. It shows which components were used, how the device was built, what sterilization and quality checks were done, and how it was labeled and shipped. KnarrTek’s medical traceability solutions build the record as scans happen instead of assembling it afterward from paper travelers.

A lot number identifies a group of devices or components made together. A serial number identifies one individual device. Both can appear in the production identifier on a UDI label. BellHawk records both and links them to the components and the production steps behind them.

A Unique Device Identifier has two parts. The device identifier identifies the product and version. The production identifier carries information that varies by unit, such as the lot or batch, serial number, expiration date, and manufacture date. BellHawk fills the production identifier from the production record when the label is printed.

BellHawk records which lots and serial numbers were in a sterilization load, the cycle and equipment used, the operator, and the result. Quality holds stay in the record until your quality team clears them, and MilramX can send alerts when a hold or a delay needs attention.

Yes. Components are scanned at receiving with supplier, lot, quantity, expiration date, and location, then linked to the work orders and devices that used them. That link is what makes a complaint traceable back to a supplier lot, and forward to every device built from it.

The complaint record links to the lot or serial number involved, which leads to the Device History Record and to the component lots used. Investigations start from the connected record, so teams spend their time on analysis instead of searching for paperwork.

This page covers medical traceability solutions for medical device manufacturers, medical supply manufacturers, and medical supply distributors, including operations that assemble, sterilize, label, and ship devices. For drug manufacturing, laboratories, and biotech, KnarrTek has separate pages with those requirements in mind.

KnarrTek works from offices in Millbury, Massachusetts and Panama City, Florida, and operates globally, with current accounts in Mexico and Canada. Both offices are reached through the same contact page, phone number, and email, so you get one team for quick, friendly answers.

No. The software supports your documentation and recordkeeping. It does not certify a business or a product, and compliance responsibility remains with the customer. Your regulatory and quality teams decide what records are required for your products.

KnarrTek offers white papers by Dr. Peter Green on topics such as inventory tracking versus materials traceability, preventing inventory errors, barcodes versus RFID for work-in-process tracking, and planning for a new ERP system. They are available from the KnarrTek white paper library.

Call 774-415-7878 or use the contact page. A short conversation about your products, labels, sterilization process, and recall or audit needs usually shows where to start. Many teams begin with component receiving and UDI labeling, then add assembly and sterilization steps.