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    ISO 14971 Risk Management: FAQs e-Book

    Questions and Answers 2 compressed

    We've gathered all the commonly asked questions about the ISO 14971 Standard together with expert answers.

    Download the Free ISO 14971 e-Book for answers.

    Here, we at deGRANDSON Training, a provider of Risk Management Courses, have assembled a comprehensive set of ISO 14971, Risk Management for Medical Devices, FAQS...

    • What is ISO 14971?
    • What is the purpose of ISO 14971?
    • What are the Benefits of using ISO 14971?
    • Is the use of ISO 14971 mandatory?
    • Is ISO 14971 intended for Medical Device Manufacturers only?
    • Do applicable regulatory requirements in ISO 13485 include ISO 14971 and other ISO Standards?
    • Where does ISO/TR 24971 apply? 
    • Can we get certified to ISO 14971?
    • What's new in the 2019 version of ISO 14971?
    • Why isn't an FMEA enough?
    • What does the lifecycle approach mean in practice?
    • Do Internal Auditors need training in ISO 14971?

    Click on the e-Book image to get your copy...

    ISO 14971 FAQs

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    Written by Dr John FitzGerald

    Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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