production control for
medical device manufacturing
document every step with safety
production control for medical device manufacturing
document every step with safety
e-DHR compliance from the start
You need compliance and the written proof of it for every part you make and label in Medical Device. From design to packaging, you need to have everything recorded for auditable control of your work. Once you put a job on the shop floor, you need to control the work, right down to every step in the process. Quantum enforces quality, directs accurate workflow and delivers compliance at every stage of production.
We have more than 25 years of experience ensuring that medical device companies have the Production Control they require for compliance. Maintain all of your certifications including 21 CFR part 11 with a platform that's ready to install today and use tomorrow. Complete Production Control for Production Operations in medical device production. Quantum.
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data-driven team insights for medical device compliance
Quantum Analytics gives medical device manufacturers total visibility into production performance, from individual operators to entire assembly teams. Whether you're maintaining FDA/ISO compliance or increasing daily throughput, Quantum provides the insight you need to stay ahead.
With built-in performance dashboards, reporting, and real-time data capture from the shop floor, you can:
✔ Monitor task, jobs, and order completion rates in real-time
✔ Evaluate team and individual output by shift, job, or work center
✔ Forecast staffing needs and resource allocation for production spikes or audits
✔ Ensure audit readiness with traceable, time-stamped activity logs
✔ Maintain control over critical handling, sterilization, and packaging steps to reduce recalls and scrap
compliance-ready, patient-safe.
designed for FDA-level control
product engineering
Design intent doesn't stop at the drawing board. From original engineering, through revision control and auditable records of work and approvals, Quantum connects engineering directly to production, ensuring every device is built exactly to spec with full visibility into changes, approvals, and revisions.
materials specification
From raw materials to sterile packaging, every input is logged, tracked, and verified. Create part-specific Bill of Materials (BOMs) for each part and ensure that the proper materials are available at each stage of production. Quantum enforces materials requirements so nothing enters production without meeting your regulatory and quality standards.
certified work
Every step of the process is documented, certified, and tied to the responsible operator. Comply with each equipment requirement for each customer with controlled work paths for each part on your shop floor and certification of operators. Quantum ensures only trained and approved personnel complete critical tasks, safeguarding compliance and patient safety.
CAPA procedures
When issues arise, Quantum makes corrective and preventive actions clear, traceable, and enforceable. Correct each production non-conformance and push automated rework routines to the proper place along with approval of each piece of rework. Identify root causes, track resolutions, and close the loop with data-backed improvements.
eDHR records
Get an automated eDHR with a record of every piece of work that was done on every serialized part from the original engineering through to every operator that touched the part in production including in-production inspection records and supervisory sign-offs. Quantum eliminates manual errors and ensures your eDHRs meet FDA and ISO requirements.
what's your manufacturing mindset?
Discover what drives your decision-making and how the right MES can help you lead with impact.
efficiency driver
As an Efficiency Driver, you’re the real innovator in your manufacturing operation. You’re always seeking ways to improve workflows, eliminate bottlenecks, and keep things running smoothly. You’re data-driven, closely tracking resources, cycle times, and overall equipment effectiveness (OEE). You’re likely looking to minimize waste and maximize throughput, and metrics that show tangible improvements in output and operational flow make you happy.
For you, Quantum is your digital production assistant, providing real-time visibility into every stage of your workflow. Features like dynamic scheduling, real-time performance monitoring, and detailed work instructions empower you to optimize resource allocation, reduce downtime, and make decisions that lead to noticeable gains in productivity and output. With Quantum, you gain the control and visibility you need to drive efficiency at every stage of production.
wish list
✔ A system with dynamic scheduling capabilities to manage variable demand and urgent production changes
✔ A tool that tracks processes and performance over time for FDA and ISO compliance documentation
✔ A system that optimizes production flow while maintaining quality control requirements
✔ A tool that gives you real-time visibility on the shop floor to prevent bottlenecks and ensure product safety
✔ A product that supports continuous improvement training to uphold regulatory standards and patient safety
cost controller
As a Cost Controller, you’re the sharp-eyed spending scrutinizer. Your primary focus is the financial health of your manufacturing operation, so you’re looking for solutions with tangible cost savings.
For you, Quantum tracks everything – material consumption, waste, labor costs, production times – and gives you a clear picture of your operation expenses. With such deep insights into your resources and processes, Quantum helps you identify areas for savings so you can make informed decisions that improve profitability.
wish list
✔ A tool that helps reduce waste and scrap while protecting regulated materials
✔ A system that tracks expenses accurately for compliance with FDA, ISO, and regulatory cost records
✔ Comprehensive reporting and analytics to monitor quality metrics and production efficiency
✔ A solution that gives you clear insights into production costs
✔ A tool that can manage all your inventory across cleanroom, assembly, and packaging environments
quality champion
As a Quality Champion, you always fight for product excellence and customer satisfaction. You are meticulous about standards, focused on eliminating defects and ensuring compliance. You understand that high quality is not just about meeting specifications but also about building trust and protecting your company’s reputation. You measure success by low defect rates, consistent reliability, and happy customers.
For you, Quantum has the dashboards you depend on to maintain the highest levels of quality: real-time monitoring of critical parameters, built-in quality checks, and end-to-end traceability of materials and processes. Quantum’s clear, visual work instructions ensure jobs are always done the right way so quality stays consistent. Quantum gives you peace of mind that you’ll always be able to uphold the highest standards.
wish list
✔ A tool that helps reduce waste and scrap while protecting highly regulated materials
✔ A system that captures and manages quality data for FDA, ISO, and EU MDR compliance
✔ A product with instant alerts and in-process quality checks to prevent defects from reaching patients
✔ Detailed audit trails and end-to-end product traceability to ensure full documentation of every device
✔ A system that enforces standardized work processes to maintain consistency in assembly operations
visibility expert
As a Visibility Expert, you’re the far-sighted planner for your manufacturing operations. You recognize that visibility is above all else and you consider the big picture and long-term goals whenever you make a decision. Your focus is on driving strategic objectives, improving agility, and positioning your operations for success in this dynamic market. You think a lot about how technology investments can drive your company’s strategic plans/objectives.
For you, Quantum provides the high-level insights you need to achieve your long-term goals. With a comprehensive view of the entire production process, Quantum enables data-driven decision-making, from capacity planning to resource allocation to future investments. With the complete, real-time visibility Quantum provides, you can set clear goals, and its scalability supports you as you succeed and grow.
wish list
✔ A solution with real-time visibility into shop floor operations to ensure compliance and reduce risk
✔ A system with complete traceability and real-time material tracking for FDA and ISO standards
✔ A system that enables clear communication between quality, production, and regulatory teams
✔ A system that provides both a high-level view of production and granular data for device records
✔ Seamless integration with ERP
✔ A system that gives you a competitive advantage in speed-to-market and regulatory approval
✔ A product that demonstrates a clear return on investment through reduced recalls and improved yield
✔ A product that is scalable for future growth, supporting new product launches and global expansion
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cut through compliance red tape
You operate in one of the most highly regulated industries in the world. Paper-based records and spreadsheets slow you down and put compliance at risk. Many manufacturers lean on homegrown tools, but they can't deliver the control or traceability the FDA and ISO require. Quantum gives you the real-time visibility, documentation, and production control to keep devices safe, compliant, and moving to market faster.


