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  • Introduction to 21 CFR Part 11 and Related Regulations

    This article provides an overview of regulations and guidelines for electronic records (data entry, storage, signatures, and approvals) used in the USA (21 CFR Part 11), EU (GMP Annex 11), and China…
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  • Elevate your Inspection Workflow for Medical Devices

    This webinar will demonstrate a smart device for traceable microscopy that helps you achieve more consistent visual inspection of medical devices across multiple users. Additionally, this device…
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  • Going Digital for Medical Device Visual Inspection

    This article discusses the reasons why paper-based documentation and reporting makes visual microscope inspection of medical devices inefficient and unreliable. It also addresses other factors…
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  • Why is Manual Visual Inspection of Medical Devices so Challenging?

    This article discusses how manual visual inspection, which is prevalent in the medical device industry, can lead to inconsistent results. It also addresses the challenges quality managers and…
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  • Fields of Application

  • Medical Device Quality Assurance & Control

    Medical Device manufacturing microscopes from Leica Microsystems help improve production efficiency while reducing muscle and eye strain from repetitive tasks, all while providing high quality optical…
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