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MES for Medical Device Manufacturing

Built for compliance. Designed for agility.

Digitize eDHRs, error-proof compliance, and adapt fast, without relying on IT. Tulip’s composable MES helps medical device manufacturers cut costs, boost productivity, and meet 21 CFR Part 820.

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  • Human-centric interfaces

    Empower operators with intuitive digital apps and guided workflows that reduce errors, speed up training, and improve audit readiness.

  • Three-month average implementation

    Deploy, validate, and see results fast and get compliant digital solutions live in weeks, not years.

  • Open and flexible

    Built on a cloud-native, no-code platform with open APIs and plug-and-play connectors for your quality systems, machines, and sensors.

  • Secure and validation-ready

    Support compliance out of the box with access controls, audit trails, and documentation that speeds validation and inspection readiness.

Join Top Manufacturers

Across manufacturing, companies are transforming their operations with Tulip.

Medical device manufacturers need composability

Traditional MES can’t keep up with evolving regulations, increased personalization, or the complexity of modern medical device production. Tulip’s composable platform gives you modular building blocks to digitize and continuously optimize operations without vendor delays or compliance tradeoffs.

Guided workflows with pick-to-light capabilities for medical device assembly

  • Support every role in a regulated environment

    Give operators guided digital workflows, enable quality teams with real-time visibility and traceability, and equip IT with governance to scale securely.

  • Adapt to product, process, or regulatory changes

    Update eDHRs, digital forms, and workflows as your product lines evolve without re coding or complex change control processes.

  • Modernize without disruption

    Digitally transform without a rip-and-replace project. Deploy apps alongside your current systems, iterate quickly, and validate as you go.

Recognized Leader in Frontline Operations

  • G2 Leader 2024
  • Leader IDC Marketscape 2024-2025
  • 4.5 rating on Gartner Peer Insights 2024
  • Challenger MES 2021, 2022, 2023
Medical Device CMES app suite

Composable MES for Medical Devices

The Composable MES App Suite for Medical Devices and Diagnostics provides an accelerated path to building a digitally-native production system.

Explore Tulip's Composable MES

Advantages of Composable MES

  • Human-Centric

    Build digital workflows that reduce operator error and training time with interfaces operators actually want to use. Add AI copilots to guide work and enforce SOPs.

  • Fast, Iterative Roll Out

    Say goodbye to all-or-nothing MES deployments. Launch right-sized, validated solutions in weeks, not months.

  • Open and Extensible

    Integrate with your existing systems PLM, ERP, QMS, and test equipment via open APIs and connectors.

  • Flexible, Validatable Data Model

    Track every unit, lot, and action with a data model designed for traceability and validation across complex device configurations.

  • Democratized Development

    Enable quality and process engineers to create validated digital solutions using no-code tools with centralized IT oversight.

  • Modern Architecture

    Leverage AI, connected systems, and real-time data to streamline quality, accelerate production, and ensure audit readiness.

Built for leading medical device manufacturers

  • Operator completing a quality test with a bionic arm.

    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 Medical Device

    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
  • ArchForm Aligner Line

    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
Frequently Asked Questions
  • What makes Tulip a leading MES solution for medical device manufacturers?

    Tulip is recognized by industry analysts and customers alike as a leading MES solution for regulated industries, including medical devices and diagnostics. Gartner and Forrester have highlighted Tulip as a pioneer in composable, no-code MES, and Tulip consistently ranks as a category leader on G2 for ease of use, customer satisfaction, and speed to value.

    Unlike rigid, monolithic systems, Tulip’s composable, no-code platform allows manufacturers to create intuitive, error-proof workflows that guide operators and reduce compliance risks. With automated audit trails, eDHR/eBR, seamless integrations with ERP, PLM, and QMS systems, and flexible data structures, Tulip enables rapid deployment, continuous improvement, and full end-to-end traceability. This combination of agility, compliance, and usability makes Tulip uniquely suited to help medical device manufacturers build it right the first time, every time.

  • How does Tulip help medical device manufacturers stay compliant with FDA, EMA, and cGMP regulations?

    Tulip embeds compliance directly into frontline workflows through features like electronic device history records (eDHR), automated audit trails, and regulation-compliant electronic signatures. This ensures every production step is documented, traceable, and tamper-proof. By capturing data in real-time from operators, machines, and connected systems, manufacturers can respond to deviations faster and be fully prepared for audits without relying on manual paperwork

  • What are the main challenges medical device manufacturers face when relying on paper-based or legacy MES systems?

    Paper-based logbooks and rigid MES systems create risks such as incomplete records, operator errors, and inefficient audits. Manufacturers often face delays in finding root causes, struggle with visibility into operations, and lose time to manual compliance documentation. Legacy MES solutions also lack flexibility for complex, high-mix assembly processes, making it harder to scale or adapt to changing regulations and market needs.

  • How quickly can manufacturers implement Tulip’s solutions, and what is the impact on operations?

    Unlike traditional MES projects that take years, Tulip enables deployment in weeks. Manufacturers gain rapid visibility into operations, accelerate new product introductions, and continuously improve processes without long IT cycles.

  • How does Tulip integrate with existing systems like ERP, PLM, QMS, and legacy equipment?

    Tulip acts as a unifying data layer, connecting seamlessly with enterprise systems (ERP, PLM, MES, QMS) as well as legacy equipment and custom devices. Through pre-built connectors, OpenAPI, and device integrations, Tulip eliminates data silos and enables end-to-end traceability. This unified ecosystem allows real-time data sharing — from CAD drawings to work orders — so manufacturers can manage change effectively and maintain a single source of truth

Apps Make Operations Better

See how Tulip helps medical device manufacturers eliminate paper, increase traceability, and reduce time-to-market with a composable MES.

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