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    Iso 14971

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    Vivek Goud
    ISO 14971 is a nine-part ISO standard that establishes a framework for risk analysis, evaluation, control, and management of medical devices. It specifies procedures for risk management by manufacturers during the product life cycle to determine safety. Compliance with ISO 14971 is required by higher level regulations and quality standards like ISO 13485. ISO 13485 is an ISO standard that represents requirements for a comprehensive quality management system for the design and manufacture of medical devices. It supersedes earlier quality standards and was most recently updated in 2016.

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    Iso 14971

    Uploaded by

    Vivek Goud
    282 views1 page
    ISO 14971 is a nine-part ISO standard that establishes a framework for risk analysis, evaluation, control, and management of medical devices. It specifies procedures for risk management by manufacturers during the product life cycle to determine safety. Compliance with ISO 14971 is required by higher level regulations and quality standards like ISO 13485. ISO 13485 is an ISO standard that represents requirements for a comprehensive quality management system for the design and manufacture of medical devices. It supersedes earlier quality standards and was most recently updated in 2016.

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    ISO 14971

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    ISO 14971

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    ISO 14971 is a nine-part ISO standard that establishes a framework for risk analysis, evaluation, control, and management of medical devices. It specifies procedures for risk management by manufacturers during the product life cycle to determine safety. Compliance with ISO 14971 is required by higher level regulations and quality standards like ISO 13485. ISO 13485 is an ISO standard that represents requirements for a comprehensive quality management system for the design and manufacture of medical devices. It supersedes earlier quality standards and was most recently updated in 2016.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    282 views1 page

    Iso 14971

    Uploaded by

    Vivek Goud
    ISO 14971 is a nine-part ISO standard that establishes a framework for risk analysis, evaluation, control, and management of medical devices. It specifies procedures for risk management by manufacturers during the product life cycle to determine safety. Compliance with ISO 14971 is required by higher level regulations and quality standards like ISO 13485. ISO 13485 is an ISO standard that represents requirements for a comprehensive quality management system for the design and manufacture of medical devices. It supersedes earlier quality standards and was most recently updated in 2016.

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    ISO 14971

    ISO 14971 is an ISO standard for the application of risk management to medical
    devices.[1] The ISO Technical Committee responsible for the maintenance of this
    standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one
    (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide
    51,[2]and ISO/IEC Guide 63.[3] The latest significant revision was published in 2007 with
    a minor update published in 2009. In 2013, a technical report ISO/TR 24971[4] was
    published by ISO TC 210 to provide expert guidance on the application of this standard.
    This standard establishes the requirements for risk management to determine the safety
    of a medical device by the manufacturer during the product life cycle. Such activity is
    required by higher level regulation and other quality management system standards
    such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first
    establishes a framework for risk analysis, evaluation, control, and management, and
    also specifies a procedure for review and monitoring during production and post-
    production.[5][6]

    ISO 13485
    ISO 13485 Medical devices -- Quality management systems -- Requirements for
    regulatory purposes is an International Organization for Standardization (ISO) standard,
    was published for the first time in 1996, that represents the requirements for a
    comprehensive quality management system for the design and manufacture of medical
    devices. This standard supersedes earlier documents such as EN 46001 and EN 46002
    (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also
    1996).
    The current ISO 13485 effective edition was published on 1st March 2016.

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