--- title: "Composable MES for Medical Device & Diagnostic Manufacturing" description: "Digitize eDHRs, error-proof compliance, and adapt fast, without relying on IT, using Tulip's composable MES." url: "https://tulip.co/solutions/composable-mes-for-medical-devices/" lang: "en" --- 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. [Request a Demo](https://tulip.co/contact-sales/) - 0 quality escapes **reported** - ↓93% in **review time** - ↓70% in **defects** - 0 shipments **with missing parts** ### 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. ## Audit-ready. Built for change. ### Start with your highest-impact operations Map your journey to address your biggest challenges first. Use your context, processes, and data to compose MVP solutions in days and connected systems in weeks. ### Every addition builds on what's already there Each new solution shares the same data model, security controls, governance framework, and integration layer. Capabilities layer, value grows. ### Value compounds as the operation grows Expand solutions across production lines, sites, and use cases, while maintaining consistency and control. As needs evolve, easily adapt your solutions. ## See a medical device plant running on Tulip Start from a working plant, then make it yours: your areas, your process, your goals [Map my plant](https://operations-composer.library.tulip.co/?entry=compose\&utm_source=tulip.co\&utm_medium=referral\&utm_campaign=composable_mes_med_dev) ![factory composer](https://tulip.widen.net/content/gy4kr23u4b/webp) ## Advantages of Composable MES - **Human-Centric** — Move beyond rigid, pre-defined MES screens and paper-on-glass solutions. With Tulip, create intuitive and time-saving workflows with AI that workers will love to use. - **Fast, Iterative Roll Out** — Say goodbye to all-or-nothing deployments that take months and disrupt operations. Use connected, reusable building blocks to create right-sized solutions quickly with Tulip. - **Open and Extensible** — No need to compromise on the systems, technologies, and devices you want to connect with. Enjoy the freedom to evolve your technology stack with Tulip’s open API. - **Flexible, Intuitive Data Model** — Start with a common data model that is human-readable, using naming conventions with operational meaning. Adapt and extend your data schema as needed. - **Democratized Development** — Give your technical and engineering teams no-code capabilities to compose solutions, while maintaining governance. - **Modern Architecture** — Take advantage of AI, connected systems, automations, and physical devices to build innovative, human-centric solutions that drive value. ## **Built for leading medical device manufacturers** **Prosthetic Manufacturer** ![prosthetic manufacturer](https://tulip.widen.net/content/ag7hvrxyvt/webp) ## 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](https://tulip.co/case-studies/personalized-prosthetic-arm/) **Laerdal** ![Laerdal error proofing](https://tulip.widen.net/content/7bucq4qwdi/webp) ## 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](https://tulip.co/case-studies/laerdal-medical/) **Orthodontic Manufacturer** ![Orthodontic manufacturer](https://tulip.widen.net/content/lvaerfppas/webp) ## 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](https://tulip.co/case-studies/custom-orthodontic-aligner/) ## FAQs ### 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. ## Transformation that compounds Your operations can't wait. See how composable systems of apps, agents, and automations solve today's operational problems and scale with what comes next. [Get a Demo](https://tulip.co/contact-sales/) [Map my plant](https://operations-composer.library.tulip.co/?entry=compose\&utm_source=tulip.co\&utm_medium=referral\&utm_campaign=composable_mes_med_dev)