Regulatory Open Forum

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  • 1.  Medical Device - Deliver project under tight timeline

    Posted 16-Jan-2021 07:40
    Hello, 
    Can anyone give an example of a time when you were able to deliver an important project of Medical Device under a tight deadline. What sacrifices did you have to make to meet the deadline? How did they impact the final deliverable? What was the final outcome?

    I would like to hear views on strategies and how do you typically handle stress level. 

    Thanks a lot in advance.
    Regards, 
    Vidita

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    VIDITA DESAI
    Regulatory affairs
    United States
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  • 2.  RE: Medical Device - Deliver project under tight timeline

    Posted 19-Feb-2021 21:04
    Hi Vidita,

    Would you be able to provide additional context for your questions?  For example, are you looking for experiences related to product development/R&D, regulatory submissions, or other types of projects (e.g. QMS certification)?

    Also, are you interested in the stress experienced by the Regulatory/Quality personnel, or by the whole team?

    Regards,

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    Camille Thorpe, RAC
    Toronto, ON
    Canada
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  • 3.  RE: Medical Device - Deliver project under tight timeline

    Posted 20-Feb-2021 02:03
    Edited by Sathya T N 20-Feb-2021 02:03
    Hi Vidita, 

    Your question seems to be more psychological. Stress as such is a factor that is tied up with every profession and it depends on the individual to prioritise their time and commitments to a given project.  Tight schedules have become the way of life. Its all about proper planning, time management and most importantly a sound health and mind. I am sure with all this, even this will pass,,,,

    Take a deep breath. Relax. 

    Good luck to you!

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    Sathya T N
    Regulatory Toxicologist
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