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 Medical Device LIMS is designed specifically for regulated manufacturing industries working to standards such as FDA 21 CFR Part 11, ISO 17025 and cGxP. Developed according to our ISO9001 accredited quality system the solution is supported by comprehensive validation documentation providing a head start to validation activities. Unique graphical configuration tools allow the Medical Device LIMS to be adapted to your specific needs while ensuring that the validated core software remains untouched.

Instantly Relate Raw Materials to Final Products

Medical Device LIMS drives quality throughout the manufacturing flow by managing and tracking the samples of raw materials, intermediate and final product, ensuring they can be quickly related to the relevant product and batch. Matrix Gemini Medical Device LIMS helps you automate and control your sample testing, and record data results, to conform to regulatory requirements.

Key Features and Benefits of the Medical Device LIMS:

Key Features

  • Batch and recipe management to link final products to raw materials and suppliers
  • Manage tests performed at each stage of every batch
  • Defined specifications and workflows
  • Automated data approval for in specification results
  • Test to manufacturing specifications
  • Customer specific product grading
  • Built-in instrument integration, calibration and maintenance and analyst certification
  • Integration with ERP and other corporate systems
  • Built in security, user by user specific access to workflow options and full audit trail

Key Benefits

  • Provides complete batch tracking, batch traceability and genealogy
  • Allows validation of each production stage
  • Ensures the integrity of the data generated
  • Management by exception reduces turnaround time
  • Track manufacturing quality
  • Maximize the value of manufactured material
  • Elimination of transcription errors and improved quality through instrument and personnel capability assurance
  • Increases organizational efficiency
  • Aids adoption of best practices and regulatory compliance with FDA 21 CFR Part 11, ISO 17025 & cGxP

Environmental Testing Ensures Sterility

The Environmental Monitoring (EM) module simplifies and automates the collecting of samples to monitor critical points around the production facility. Pre-defined testing schedules guide collection of samples from specified locations. Graphical mapping of test results to sample point locations provides instant visualization of if problems occur. Out of specification test results may be linked to corrective and preventive actions (CAPA) which may 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 complex stability management programs to be setup to manage storage and testing of product to derive shelf-life statistics.

A Brighter Future with an Efficient LIMS

Designed with ‘usability’ at its heart users find the graphical workflow easy to understand, simple to use and highly flexible.

A Matrix Gemini Medical Device LIMS helps to eliminate bottlenecks through the QC laboratory, automate and streamline processes, and reduce human error. This results in fewer manufacturing delays and improved profitability for the business, while improved efficiency in the laboratory allows staff resources to add value rather than chase down discrepancies in data and lost sample information.

Find Out More

For more detailed information see our Matrix Gemini Manufacturing LIMS Brochure

Case Study

Discover how Matrix Gemini LIMS is used at this medical device manufacturer

Next Steps

To discover more about our medical device LIMS please contact us to discuss your needs or a web demonstration.