Medical Device LIMS
Medical devices such as joint implants and stents are manufactured in a tightly regulated sterile environment to ensure patient safety.
A LIMS for Regulated Manufacturing of Medical Devices
Matrix Gemini LIMS is designed specifically for regulated manufacturing industries operating to standards such as FDA 21 CFR Part 11, ISO 17025 and cGxP. Developed in accordance with our ISO 9001 accredited quality system, the solution is supported by comprehensive validation documentation that provides a head start for validation activities. Unique graphical configuration tools allow the Medical Device LIMS to be tailored to your specific requirements while ensuring the validated core software remains untouched.
Instantly Relate Raw Materials to Final Products
The Medical Device LIMS drives quality throughout the manufacturing flow by managing and tracking samples of raw materials, intermediate and final products, ensuring they can be rapidly linked to the relevant product and batch. Matrix Gemini Medical Device LIMS helps you automate and control your sample testing and record data results to satisfy regulatory requirements.
Key Features & Benefits
Batch and recipe management linking final products to raw materials and suppliers – complete batch tracking, traceability and genealogy
Manage tests performed at each stage of every batch – validate each production stage
Defined specifications and workflows – ensure data integrity
Automated data approval for in-specification results – management by exception reduces turnaround time
Test to manufacturing specifications – track manufacturing quality
Customer-specific product grading – maximise the value of manufactured material
Integrated instrument interfacing, calibration, maintenance and analyst certification – eliminate transcription errors
Integration with ERP and other corporate systems – increase organisational efficiency
Built-in security with user-specific access and full audit trail – aids compliance with FDA 21 CFR Part 11, ISO 17025 & cGxP
Environmental Testing Ensures Sterility
The Environmental Monitoring (EM) module simplifies and automates the collection of samples to monitor critical points around the production facility. Pre-defined testing schedules guide collection from specified locations. Graphical mapping of test results to sample point locations provides instant visualisation of any problems. Out-of-specification test results may be linked to corrective and preventive actions (CAPA), which can be easily logged within the LIMS.
Manage Competency, Quality Cycles and More
The Matrix Gemini Medical Device LIMS also manages staff competency, instrument calibration and maintenance, product grading and investigations into quality lapses using CAPA. A stability module enables long-term product stability studies to be conducted and monitored.
Get a Free Demo Today
Choose a future-proof, highly adaptable system that enhances accuracy and efficiency across your data management workflows. Matrix Gemini LIMS delivers lasting flexibility and compliance, making it a smart investment that transforms ongoing projects while supporting growth and evolving laboratory needs.
