Medical Device Manufacturing :
precision, compliance, zero-defect
Contact usThe Challenge
In MedTech, precision isn’t just performance, it’s patient safety. Medical devices manufacturers must comply with FDA 21 CFR Part 11 and ISO 13485 requirements. All while ensuring process validation, data integrity, and cybersecurity. CLOOMA supports medical device manufacturers with a unified, compliant ecosystem that simplifies validation, streamlines audits, and strengthens confidence from prototype to final inspection.
Regulatory Compliance
Electronic records, e-signatures, and automated audit trails compliant with FDA 21 CFR Part 11 make traceability effortless. Each deviation, rework, or batch result is securely stored and instantly retrievable for inspections.
Continuous process validation
CLOOMA tracks capability and stability in real time, automatically documenting validation data.Processes remain under statistical control, aligned with FDA QMSR expectations for proactive quality management.
Data integrity & cybersecurity
Encrypted storage, user authentication, and redundant hosting meet FDA cybersecurity standards, ensuring data protection and continuity.
Simplicity that empowers
Operators and quality engineers navigate with ease.CLOOMA provides guided workflows and live metrics, freeing teams from manual data entry and letting them focus on what matters: precision and compliance.
The CLOOMA Advantage
CLOOMA makes regulatory compliance an engine of excellence.
It ensures validated, documented, and repeatable processes, accelerating audits, reducing risk, and enhancing product reliability. Because in MedTech, every second counts and every detail matters.
See how CLOOMA
adapts to medical devices manufacturing
CLOOMA helps medical manufacturers achieve the precision, repeatability, and compliance required to deliver safe, effective, and high-quality devices.
Real-time production monitoring
View all your production data on a single page, in real time. Automatic calculation of quality indicators (Cp, Cpk, Pp, Ppk...) alerts in case of deviations and root cause detection.
Traceability
In a snap, find any batch manufactured by machine / operator / measuring instruments and create a customizable report to meet your customer's most precise requirements.
Manufacture high-value-added parts
Reduce srap by automating machine tool set-up to get the first part right.
Link to your ERP
Connect CLOOMA with your other production management software thanks to our native APIs.
Workshop communication
Display you workshop's key information, customize and manage your KPI's with oour sahreable dashboards.
Connect all your measuring instruments
Automatically create control cards by connecting all the measuring instruments in the workshop. Bluetooth, file, R232, CLOOMA can do it all.
Role-based access management
Limit access to what's strictly necessary and manage access rights to ensure that an operator is authorized to create / modify the document.
Optimized sampling inspection
Minimize the number and size of sampling operations thanks to existing links between modules and our many innovations, progressive acceptance sampling, automated dynamization and more.
Discover our Case Studies
LISI
Automotive / Aerospace / Medical
95% reduction in scrap rate
75% reduction in machine tool set-up time
75% reduction in machine tool set-up time
Utilita
Defense / Aerospace / Automotive
We've always belived in the importance of innovation to stay competitive.
Kartesis
Automotive / General Mechanics
We've very proud of the way our workshop has evolved thanks to Closed Loop Manufacturing software
