より高い品質を
追跡可能な顕微鏡デバイス Exalta
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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