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    Alex Tan
    This document discusses regulations for medical device testing. It outlines three key points: 1) Medical devices must undergo testing to evaluate safety and effectiveness. Tests are required to receive marketing approval. 2) Certain high-risk devices require clinical investigations where devices are tested on humans. Clinical investigations help identify any potential risks. 3) Devices must be manufactured and documented according to quality standards. Documentation shows devices meet requirements for marketing approval.

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    Alex Tan
    5 views1 page
    This document discusses regulations for medical device testing. It outlines three key points: 1) Medical devices must undergo testing to evaluate safety and effectiveness. Tests are required to receive marketing approval. 2) Certain high-risk devices require clinical investigations where devices are tested on humans. Clinical investigations help identify any potential risks. 3) Devices must be manufactured and documented according to quality standards. Documentation shows devices meet requirements for marketing approval.

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    This document discusses regulations for medical device testing. It outlines three key points: 1) Medical devices must undergo testing to evaluate safety and effectiveness. Tests are required to receive marketing approval. 2) Certain high-risk devices require clinical investigations where devices are tested on humans. Clinical investigations help identify any potential risks. 3) Devices must be manufactured and documented according to quality standards. Documentation shows devices meet requirements for marketing approval.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    5 views1 page

    Img 0003

    Uploaded by

    Alex Tan
    This document discusses regulations for medical device testing. It outlines three key points: 1) Medical devices must undergo testing to evaluate safety and effectiveness. Tests are required to receive marketing approval. 2) Certain high-risk devices require clinical investigations where devices are tested on humans. Clinical investigations help identify any potential risks. 3) Devices must be manufactured and documented according to quality standards. Documentation shows devices meet requirements for marketing approval.

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