A smarter way to track and manage medical device production
Capture operator and equipment data as part of the workflow without manual entry or paper logbooks. Automatically track part history, component-level genealogy, and process data to generate audit-ready records and catch deviations before they become quality issues.
React faster to deviations and improve production reliability
Give operators the tools to flag defects, deviations, or downtime in real time. Track cycle time, first-pass yield, and unit-level genealogy to surface issues before they impact quality. Balance workloads across stations to maintain delivery and inspection readiness.
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Elevate productivity
bottlenecks in manual assembly, testing, or inspection using real-time alerts—no more waiting for daily reports.
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Create a digital audit trail
Maintain GxP-compliant records with e-signatures, timestamps, and user access controls. Know who did what, when, and under what conditions.
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Accelerate quality reviews
Resolve issues faster with live data. Use review-by-exception to cut Device History Record (eDHR) review time.
Recognized Leader in Frontline Operations
An easier way to digitize and monitor production
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No-Code App Editor
Build easily validated, user-friendly apps that improve visibility and compliance without writing code. Start fresh or adapt pre-built templates for eDHRs, logbooks, or inspection records.
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Flexible Interfaces
Run apps on tablets, HMIs, and desktop workstations across assembly, testing, and packaging stations. No IT bottlenecks, no workflow disruption.
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Edge Connectivity
Capture data from inspection stations, sensors, and shop floor systems while preserving validated workflows and data integrity.
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Integrations With Your Existing Systems
Sync operator activity and production data with your ERP, QMS, and PLM systems to ensure traceability and simplify compliance reporting.
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Visualize Operator Data
Track cycle times, yield, deviations, and environmental conditions to identify risks and continuously improve process reliability.
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GxP-Ready Platform
Tulip includes validation documentation and SOP templates, helping teams meet FDA and ISO 13485 requirements faster.
Unlock Live Production Insights
Get real-time visibility across build, inspection, and packaging with automated data capture-enabling faster, compliant decisions that reduce release times and protect patient safety.
Built for leading medical device manufacturers
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Custom Prosthetic Manufacturer Decreases Custom Medical Device Assembly by 60% with Tulip
See how a custom medical device manufacturer reduced the cost of quality and time to market by automating data collection through digital work instructions.
Read the Case Study -
Laerdal Error-Proofs Medical Kit Assembly with Vision Verifications
Learn how Laerdal streamlines their kitting procedure and uses computer vision to reduce defects across thousands of products shipped to zero.
Read the Case Study -
Orthodontic Manufacturer Ensures Compliance of Custom Orthopedic Aligner Manufacturing with an End-to-End Solution Using Tulip
See how Tulip’s reliable eDHRs helped orthodontic manufacturer scale quickly and double their production capacity.
Read the Case Study
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Tulip captures unit-level data from operators, machines, and sensors to provide a complete digital record of every step in the build process. With automatic genealogy tracking, you can trace each finished device back to its components, materials, and operators. This end-to-end visibility reduces risk, simplifies investigations, and ensures full compliance with FDA and ISO traceability requirements.
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Yes. With Tulip, all operator actions, inspections, and process parameters are recorded digitally and verified in real time. Review-by-exception highlights only deviations or missing entries, allowing quality teams to focus where it matters. This significantly reduces Device History Record (DHR) review cycles, helping you release products faster without sacrificing compliance.
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Every activity in Tulip is automatically logged with timestamps, e-signatures, and access controls, creating a complete audit trail. Supervisors and auditors can instantly see who performed which step, when, and under what conditions. This reduces the burden of manual documentation and ensures you’re always prepared for FDA or notified body inspections.
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Tulip apps guide operators through standardized workflows, replacing paper logbooks and manual data entry. This reduces errors, shortens training time, and gives operators confidence they’re following the right steps. Operators can also flag deviations or downtime instantly, helping supervisors react faster to issues and maintain production reliability.
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Tulip connects directly with ERP, PLM, and QMS systems to ensure production data flows seamlessly into your compliance and reporting processes. On the shop floor, it integrates with inspection stations and sensors, capturing data at the source. This interoperability ensures full traceability without forcing you to replace existing systems or equipment.
Improve your production tracking capabilities with Tulip
Digitize your production workflows and gain real-time traceability across assembly, testing, and packaging, with built-in compliance from day one.