The creation of a clinical review

    Resource constraint shortly before product launch

    Our assignment: The client was in desperate need of a Clinical Review. The challenges: A very tight timeline. A further complication: The Medical Device which is a product with no therapeutic benefit, has little to no previous and or helpful information. The good news: The client has created an internal documentation that is of very high quality.

    Our qtec expert has taken over this assignment and has taken it upon herself to dive deeply into the internal documentation; with great success. Within four weeks, she was able fulfill the requirements from the MDR and MEDEV 2.7.7. Rev 4 and thus finalize the clinical review.

    Due to the close cooperation and constant communication between the qtec team and the costumer, all of the necessary work packages could be accomplished in a timely manner, in time for the launch of the product.

    Projekt Key Figures

    Size of the customer company
    8.000 employees
    Size of the qtec team
    1 Medical Writer
    Time between request and start of the project
    21 days
    Total duration of the project
    4 weeks
     
    

    Our expert knowledge for your success

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    We have in-depth expertise in Medical Device Regulatory Affairs worldwide. I can answer your questions about MDR and put together a project team for you upon request.

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