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  • 医療機器製造

    薬事申請(RA:Regulatory Affairs) および QA/QC 文書のための確かな画像取得・分析: ライカ マイクロシステムズの顕微鏡ソリューションは、医療機器の品質管理で信頼性の高い外観検査・ドキュメンテーションを実現します。
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  • Science Lab Topic: Quality Assurance

    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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  • Science Lab Topic: Quality Assurance

    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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  • Science Lab Topic: Quality Assurance

    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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  • Science Lab Topic: Quality Assurance

    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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