a
.

    News & Commentary on ISO Management System Standards

    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

    Got a Question we still need to answer?

    We'd love to hear it and, if possible, answer it for you.  Just use our Support Ticket System.  You'll find a Knowledge Base there that might have an immediate answer for you. Otherwise, fill in a Ticket.

    If you would like more, please visit deGRANDSON Support Ticket.

    View our Risk Assessment & Risk Management Courses

    Related Articles


    deGRANDSON Global is an ISO Certified Educational Organization

    ISO Compound Logo-2-1 - compressedIn October 2021, we secured certification to three education-related ISO Standards.  We now have a university-grade management system in place conforming to the requirements of  …

    • ISO 21001, Educational Organizational Management System,
    • ISO 29993, Learning Services outside formal Education,  and
    • ISO 29994, Learning Services – additional requirements for Distance Learning.

    We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which, in our opinion, are commercially compromised), it is based on independent third-party assessment.  It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.

    We have Offices in Didsbury, Manchester, UK, and Pembroke Pines, Florida, USA. Our Head-office is in Limassol, Cyprus 


     

    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
    Find me on:
     

    Subscribe to Email Updates

    Recent Posts