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    ISO 13485 Certification: 26 FAQs e-Book

    Questions and Answers 2 compressed

    We've gathered all the common ISO 13485 questions

    about Certification together with expert answers.

    Download the Free ISO 13485 Certification e-Book for answers

    Here, we at deGRANDSON Training, a provider of ISO 13485 training, have assembled a comprehensive set of ISO 13485 Certification FAQS... 

    The Questions Answered

    • What is ISO?
    • What is ISO 13485?
    • What is the purpose of ISO 13485?
    • What is a Medical Device Management System (MDMS)?
    • What is the Purpose of a Medical Device Management System?
    • Who Needs a Medical Device Management System?
    • What are the Benefits of a Medical Device Management System?
    • What is ISO 13485 Certification?
    • Do You Need ISO 13485 Certification?
    • Who needs ISO 13485 Certification?
    • Does ISO 13485 Certification require the services of a Notified Body?
    • What are the Benefits of ISO 13485 Certification?
    • Is ISO 13485 Feedback the same as ISO 9001 Customer Satisfaction?
    • Why does ISO 13485 call for documentation many times while ISO 9001 does not?
    • Is ISO 13485 intended for Medical Device Manufacturers only?
    • Do applicable regulatory requirements mentioned in ISO 13485 include ISO 14971 and other ISO Standards?
    • How much does ISO 13485 Certification Cost?
    • Who issues ISO 134851 Certification Certificates?
    • How to get an ISO 13485 Certificate
    • How to Choose a Certification Body?
    • Are online ISO 13485 Certificates you can get within 30 days legitimate?
    • Why is it Important to Get Certified by the Proper Certification Body?
    • How does the ISO 13485 Certification Process Go?
    • How to check the ISO 13485 Certification of an organization?
    • Do Management Representatives or others responsible for an MDMS need training?
    • Do Internal Auditors need training?

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

    ISO 13485 FAQs

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    • ISO 21001, Educational Organizational Management System,
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    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 globally by schools, colleges, and universities to demonstrate competence.


    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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