Medical Devices

Verify material identity and manage precise assembly across multiple work centers. Supports discrete assembly and component batching with full MMR traceability.

Automate batch routing, input verification, tool management, and enforced line clearance between assembly steps to meet device specifications without manual gaps.

Embed in-process quality checks and mandatory line clearance at every stage, ensuring no production moves forward without validation.

Capture materials, processes, inspections, and approvals automatically into a compliant eDHR—eliminating paper and accelerating audit readiness.

Assign UDI labels, serialization, lot codes, and expiration dates automatically—ensuring full device traceability from components to shipment.

Enforce FDA 21 CFR Part 820, ISO 13485, and EU MDR standards within production workflows, with every action and record system-validated for audits.

Catch and correct process, product, and supplier non-conformances immediately—protecting device approvals and reducing audit findings.

Accelerate CAPA closure from audits, deviations, and complaints with structured root cause workflows built for regulatory defense.

Stay audit-ready at all times with fully traceable records, automated compliance evidence, and instant retrieval during FDA or ISO inspections.

Link incoming QC, stability, and release testing data directly into batch records and DHRs—ensuring no non-compliant device reaches market.

Enforce validated role-based training, certifications, and qualifications—avoiding audit citations and strengthening workforce compliance.

Control every SOP, specification, and work instruction with real-time approvals, change tracking, and audit trails to meet ISO 13485 and FDA standards.

Log deviations at the point of detection and automatically assess regulatory and production impacts—limiting risk escalation.

Track and verify calibration, maintenance, and validation events for production and lab equipment—ensuring devices are built with qualified assets.

Automate document approvals, CAPA sign-offs, and deviation closures with system-controlled electronic signatures and full audit logs.

Block use of restricted, obsolete, or non-approved materials with automated inventory controls—preventing unapproved materials from entering device production.

Capture material receipts with full lot/serial traceability, verifying materials against PO, Certificate of Analysis (CoA), and quarantine requirements before approved putaway.

Streamline picklists, kitting, and dispensing workflows—ensuring the right lots, components, and quantities are used per work order, with full line clearance enforcement.

Automate outbound shipment picking, packing, and labeling—ensuring device traceability, lot assignment, and real-time shipping documentation.

Track raw materials, subassemblies, and finished goods across multiple warehouses, coolers, and production zones—ensuring inventory accuracy for batch and DHR linkage.

Prevent non-approved, expired, or restricted materials from being picked or issued—supporting regulatory compliance and protecting device integrity.

Enforce warehouse controls required under FDA 21 CFR Part 820, including acceptance activities, identification, status control, and recordkeeping.

Maintain complete visibility of raw materials, subassemblies, and finished goods by batch, lot, and serial number—accelerating audits and supporting rapid recalls.

Automate expiry tracking and FEFO (First Expired, First Out) rotation—ensuring no expired materials are issued to production or shipped.

Configure multiple warehouse zones, quarantine areas, controlled storage conditions, and real-time locator management to match your operational layout.

Generate compliance-ready inventory reports, lot genealogy, and transaction logs automatically—supporting faster audits and regulatory submissions.