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Medical Device LIMS

Medical devices, such as joint implants and stents, are manufactured in a tightly regulated sterile environment to ensure patient safety.

Matrix Gemini Medical Device LIMS

A LIMS for regulated manufacturing of medical devices

Drive Quality Throughout the Manufacturing Flow

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.

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Key features & benefits of the Medical Device LIMS:

  • Batch and recipe management to link final products to raw materials and suppliers

    Provides complete batch tracking, batch traceability and genealogy

  • Manage tests performed at each stage of every batch

    Allows validation of each production stage

  • Defined specifications and workflows

    Ensures the integrity of the data generated

  • Automated data approval for in specification results

    Management by exception reduces turnaround time

  • Test to manufacturing specifications

    Track manufacturing quality

  • Customer specific product grading

    Maximize the value of manufactured material

  • Built-in instrument integration, calibration and maintenance and analyst certification

    Elimination of transcription errors and improved quality through instrument and personnel capability assurance

  • Integration with ERP and other corporate systems

    Increases organizational efficiency

  • Built in security, user by user specific access to workflow options and full audit trail

    Aids adoption of best practices and regulatory compliance with FDA 21 CFR Part 11, ISO 17025 & cGxP

Environmental Monitoring (EM) module

Environmental testing ensures sterility

Stability Management Programs

Manage competency, quality cycles and more

Easy to Understand, Simple to Use and Highly Flexible

A brighter future with an efficient Medical Device 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.

Manufacturing Cover

Medical Device Users

Case Studies

Medical Devices

SPD Adopt Matrix Gemini LIMS to Manage Pregnancy Studies

Driving an integrated approach to laboratory management Swiss Precision Diagnostics (SPD) is using Matrix Gemini LIMS to manage volunteer sample collection, laboratory testing and their clinical biobank. The new system streamlines laboratory operating processes and will ensure data is easier to find and use.

Solution: LIMS

Swiss Precision Diagnostics (SPD)

Let’s Talk

Ready to get started? Contact us today.

Let’s connect and we’ll arrange a Matrix LIMS demo.