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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…

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…

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…

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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Aparelhos médicos

Captura e análise de imagem confiáveis para sua documentação para Assuntos Regulatorios e Garantia da Qualidade

Mercados de microscopia industrial

Maximizar o tempo de atividade e atingir as metas de forma eficiente ajuda seu resultado final. As soluções de microscópio Leica podem fornecer uma visão dos menores detalhes da amostra, bem como…