Go to live demoMedical Device Manufacturers
Run compliant, audit-ready operations with a single platform built for regulated manufacturers.
Compliance and Complexity at Every Step
Medical device manufacturing is one of the most demanding industries. Every part must be traceable, every change documented, and every process compliant with regulations like FDA 21 CFR and ISO 13485. Yet many small and mid-sized manufacturers still rely on spreadsheets, shared drives, and email to manage BOMs, revisions, and supplier updates. The result is wasted time, higher risk of errors, and stress when audits arrive.
Confidence with PLM + MRP in One Platform
Aligni brings Product Lifecycle Management (PLM) and Material Requirements Planning (MRP) together in a single system built for small and mid-sized manufacturers. BOMs, CAD files, specifications, test results, and quality records live in one place, so engineering, quality, production, and suppliers are always aligned. You get complete visibility from design through production — with fewer errors, faster approvals, and the traceability you need to stay compliant.
Where to Start with Medical Device Manufacturing
You don’t have to overhaul everything at once. Start with the essentials:
Establish a Single Source of Truth
Import approved components and BOMs into Aligni to ensure engineering, quality, and production all work from the same controlled data.
Centralize and Secure Documentation
Use Vaults to store controlled files and share with suppliers and auditors — ensuring version control and compliance visibility.
Gain Visibility into Production
Manage sales orders as production builds within Aligni’s MRP functionality so you always know what can be built and when.
Identify Compliance Risks Early
Leverage the Material Shortage Report to identify compliance gaps and production delays before they become issues.
Track Revisions with Compliance in Mind
Capture and document design updates so product changes flow seamlessly into purchasing and production while preserving an audit-ready trail.
Implement Serialization and Traceability
Assign serial or lot numbers to components and finished devices, ensuring every part is traceable from supplier through production and into the field.
One System to Manage Complexity
Aligni gives medical device teams unified control over design, materials, and manufacturing—reducing risk, improving visibility, and keeping every process audit-ready.
Connected Data from Design to Build
Stop chasing files across folders and emails. Aligni connects BOMs, specifications, and quality records so every build is based on approved, compliant data. Duplicate entry disappears, revisions stay current, and production flows without costly mistakes.
Why it matters:
Medical devices rely on precision. With Aligni, engineering, quality, and production always pull from the same approved source. That alignment eliminates version confusion and ensures full traceability—key for regulatory audits and product reliability.
Engineering Change Management that Stays Audit-Ready
Change is constant in medical device manufacturing. Aligni’s built-in ECM workflows capture requests, approvals, and implementations in one structured process. Every update is traceable and every decision documented.
Key benefits:
- Links changes directly to affected BOMs, builds, and components
- Automatically notifies relevant stakeholders to accelerate approvals
- Keeps a full audit trail to simplify FDA or ISO compliance reviews
This approach ensures product updates are implemented safely, quickly, and consistently across departments—without losing documentation or introducing risk.
Proactive Inventory Management
Specialized components are expensive, and balance is everything. Aligni ties demand directly to inventory, giving visibility into what’s on hand, what’s coming, and what’s at risk. Forecasting, lead-time visibility, and safety stock tools keep production running without excess cost or expired parts.
With Aligni, you can plan long-lead components earlier, adjust stock levels based on usage, and consolidate purchasing for cost efficiency—all while maintaining compliance for serialized or lot-tracked materials.
Standardized Quality Processes
Quality isn’t a phase—it’s part of every build. Aligni standardizes inspections for incoming parts, in-process assemblies, and finished devices. Each result is logged in the item master, creating a complete quality record that’s available across teams.
This consistency supports continuous improvement and audit readiness.
- Consistency across batches ensures repeatable results
- Efficiency through standardized inspection workflows
- Traceability that links each inspection to the corresponding device record
Serialization and Traceability Made Simple
For medical device manufacturers, every component matters — and every one must be traceable. Aligni helps provide full visibility from supplier to shipment, recording serial and lot numbers across builds, assemblies, and finished products.
With Aligni, serialized components are automatically linked to their BOMs, suppliers, and quality results, giving teams a clear record of how and where every part was used. Whether you’re preparing for an FDA audit or analyzing field performance, the data is already organized and ready.
What Aligni delivers:
- Complete traceability — Every part is connected to its build, supplier, and revision history.
- Lot and serial tracking — Identify affected devices in case of recall or inspection.
- Compliance confidence — Help meet FDA and ISO documentation standards without extra overhead.
This level of visibility isn’t just for auditors—it’s operational intelligence that helps teams prevent quality issues before they reach production.
Vaults for Secure Supplier Collaboration
Vaults provide a secure, centralized workspace for sharing designs, test data, and controlled documents with suppliers. Access is managed, updates sync automatically, and version conflicts disappear.
Unlike shared drives or email attachments, Vaults maintain full control over what’s shared and when—ensuring suppliers always work from current, approved files while protecting sensitive design data.
Smarter Procurement Tools
Aligni equips buyer/planners with the insights to act before disruptions occur. Vendor performance tracking, historical pricing, and lead-time metrics turn procurement from reactive to strategic.
Procurement teams gain:
- Visibility into supplier reliability and on-time delivery rates
- Real-time pricing trends for better negotiation
- The ability to forecast risk and identify alternate suppliers early
Together, these tools help medical device manufacturers reduce lead times, improve supplier accountability, and maintain steady production flow—without the weight of traditional ERP systems.
Medical Device Manufacturing Frequently Asked Questions
Expedite the Evaluation
Evaluating business software shouldn’t take months. Aligni makes it simple to go from login to live results — no complex setup, no IT support required.
- Test drive a live demo and experience Aligni’s workflows right away. Invite colleagues, load real data, and see how it fits your operations.
- Start a 30-day free trial with free onboarding to get your team moving fast. Importing services are available to help you hit the ground running.
