Regulatory Open Forum

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  • 1.  Technical File

    This message was posted by a user wishing to remain anonymous
    Posted 15-Aug-2017 09:21
    This message was posted by a user wishing to remain anonymous

    Hello,  Does anybody know of a course on writing a Medical Device Technical File?  Thank you in advance.


  • 2.  RE: Technical File

    Posted 16-Aug-2017 00:49
    Hi - BSI has a course on technical writing.

    https://bsi.learncentral.com/shop/Course.aspx?id=2548&name=Creating+and+Maintaining+Compliant+Technical+Files+and+Design+Dossiers&_ga=2.223292191.544065022.1502858908-1185256844.1502858908

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    Timothy Lee
    Seattle WA
    United States
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  • 3.  RE: Technical File

    This message was posted by a user wishing to remain anonymous
    Posted 16-Aug-2017 14:03
    This message was posted by a user wishing to remain anonymous

    Thank you for your response.  The course that BSI has to offer is onsite for multiple employees.  I'm the only one at our company that will need it so it's not a good fit for us.


  • 4.  RE: Technical File

    Posted 16-Aug-2017 15:27
    Dear A,

    I've been providing customized training (how to draft "Technical Documentation/File") in several sessions (5 sessions - 60 or 90 min each session) to individuals, groups or firm employees. 

    If interested, you may contact me offline. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.