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  • ISO

    ISO 9001 vs ISO 13485: Key Differences for Quality Management

    eLeaP Editorial Team

    May 9, 2025

    9 min read

    ISO 9001 vs ISO 13485: Key Differences for Quality Management

    Quality management systems (QMS) are essential frameworks ensuring consistent product and service quality. ISO 9001 and ISO 13485 are two of the most recognized QMS standards globally, each with distinct purposes and applications. While they share a common foundation, understanding the differences between ISO 9001 and ISO 13485 is crucial for implementing the appropriate quality […]

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  • ISO 14971

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    eLeaP Editorial Team

    November 13, 2024

    18 min read

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    Abstract ISO 14971 is one of the most widely accepted standards that offer a coherent process for managing medical device risks. This paper aims to evaluate the incidence of risks, regulatory provisions, and risks to patients concerning the entire lifecycle of a device. It also includes an extensive examination of procedures for assessing and controlling […]

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  • ISO 13485

    ISO 13485 Ensuring Quality and Safety in the Medical Device Industry

    eLeaP Editorial Team

    August 31, 2024

    17 min read

    ISO 13485 Ensuring Quality and Safety in the Medical Device Industry

    A Comprehensive Guide to Standards, Implementation, and Future Trends Introduction to ISO 13485 What is ISO 13485? ISO13485 is a worldwide standard made just for the quality management systems (QMS) of groups that work with medical devices. From conception, design, and production to servicing and decommissioning, ISO 13485 ensures that quality and safety remain important […]

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