Run medical device manufacturing with an FDA-grade cloud ERP built for regulated environments. Maintain cradle-to-grave traceability with serial genealogy and complete device and batch history for audits and recalls. Support FDA CFR Part 11, ISO 13485 – reducing paper-based systems.
AI-powered ERP built to help medical device manufacturers meet strict regulatory and quality requirements while managing operational complexity. Connect quality, compliance, production, and financials through integrated processes. And gain real-time visibility across inventory, purchasing, manufacturing, and finance with preconfigured industry-specific functionality.
Track devices, components, and materials across their full lifecycle with complete visibility. Maintain device and batch history records (DHRs) for audits and recalls, and support serial genealogy and lot traceability to ensure full accountability from production through post-market.
Manage serialized devices and lot-controlled materials with clear linkage across production, quality, and orders. Connect serials and lots to every step of the process, enabling faster root-cause analysis and containment to limit the impact of defects, deviations, and recalls.
Reduce risk with validation-ready systems and aligned compliance and financial controls. Maintain electronic records and audit trails in line with FDA 21 CFR Part 11, and support ISO 13485, GMP, and global regulatory requirements across operations.
Capture nonconformances and quality events within controlled workflows. Enforce quality processes directly in ERP, and link issues to production, materials, and orders – maintaining traceability, ensure consistency, and support compliant execution across regulated operations.
Manage corrective and preventive actions within a structured, auditable process. Track root causes, actions, and outcomes, and ensure accountability through to closure, helping reduce recurring issues and maintain compliance across quality and production workflows.
Generate complete device and batch history records (DHRs) across materials, production, and quality events. Compile audit-ready documentation for inspections, recalls, and reporting, and see how each device or batch was built, tested, and released.
Provide a real-time view of regulated inventory across materials and components. Control purchasing, handling, and usage with full visibility, and reduce shortages, excess stock, and the risk of using nonconforming or expired materials in production.
Support discrete and continuous manufacturing processes in one system. Manage multiple production paths and product configurations. And maintain control across device types – from consumables such as syringes and tubing to complex equipment like imaging and monitoring systems.
Link production activity directly to financial results to maintain accurate cost visibility. Track materials, labor, and overhead, and gain insight into margins and operational performance across the device lifecycle and product lines.
Balance capacity across constrained, regulated resources such as cleanrooms, skilled labor, and validated equipment. Respond quickly to changes in demand, priorities, or regulations – improving delivery performance without relying on manual replanning.
ERP for SMB
Establish regulatory discipline without heavy overhead using ERP built for medical device manufacturing. Replace manual, paper-based quality and compliance tracking, and support product growth without breaking processes. Execute quickly with configurable PLM to manage regulated environments and evolving requirements.
Why it’s different
Embeds regulated workflows into daily operations. Reduces reliance on spreadsheets and supporting audit readiness with limited IT resources.
ERP for enterprise
Manage complex, regulated operations at scale while maintaining consistency across products, regions, and regulations. Support lifecycle accountability from development through post-market, and connect quality, manufacturing, and financial data to maintain control across your global business.
Why it’s different
Scales traceability and control across sites without custom frameworks. Supports global compliance without fragmenting operations.
INFOR CLOUDSUITE SOLUTIONS
Discover medical device manufacturing solutions that are natively connected to ERP for visibility, quality, and control – across all your operations.
INFOR VELOCITY SUITE
Infor Velocity Suite is an all-inclusive AI package that pairs with every Infor CloudSuite – industry-specific AI agents, GenAI, process mining, and automations, plus a team of experts to implement it for you. One flat fee, no matter where you’re starting from. It’s the simplest way to put AI to work across your business – and ultimately, to become an agentic enterprise.
BENEFITS
Reduce effort required to prepare for audits and scrutiny with better visibility into records and processes. Respond quickly to issues, recalls, and regulatory requests, and maintain confidence as requirements evolve across your products and markets.
Deploy digital quality and compliance management with paperless validation and standardized workflows. Reduce compliance overhead, inspection prep, and manual documentation – all while improving consistency across your regulated operations.
Maintain consistency across regions and product lines while also supporting growth. Keep operations aligned as complexity increases and avoid fragmentation by managing regulated processes within a single, connected system.
Use more connected data to gain insight into quality, production, and performance across operations. Identify risks and bottlenecks earlier, track trends across processes, and support more confident decision-making across your teams and sites.
USE CASES
Explore real-world examples of how medical device manufacturers bring innovative technologies, devices, and equipment to the healthcare industry.
Coordinate design transfer through first production runs – while maintaining control as requirements change late in development. Reduce disruption during ramp-up to commercial manufacturing and support a smoother transition into regulated production.
Identify affected products and batches quickly with full clarity. Coordinate response activities across teams and sites. Minimize business impact during high-risk situations by maintaining control over traceability and communication.
Maintain oversight and complete historical visibility over devices produced and sold over many years. Manage updates, changes, and replacements without losing traceability. Reduce risk as products age and regulatory requirements evolve.
Adapt operations to different regulatory environments while still staying consistent across processes. Support regional requirements without fragmenting systems, and increase oversight as products and distribution expand globally.
Resources
Explore all Infor solutions for the industrial manufacturing industry