How PMCF is evaluated by your Notified Body? [Matthias Fink - TÜV SÜD]

Поделиться
HTML-код
  • Опубликовано: 29 окт 2024

Комментарии • 8

  • @alpadodhiya3176
    @alpadodhiya3176 2 года назад +2

    Informative podcast, thank you Mr. Monir !!

  • @jrlarbi8310
    @jrlarbi8310 2 года назад +2

    Great insights and clarification points Monir. Thanks 👍🏾

  • @YYSSkkk
    @YYSSkkk 2 года назад +1

    Thanks a lot!

  • @riyagupta7221
    @riyagupta7221 2 года назад +1

    Hi Monir..I have a question regarding number of customer feedbacks and PMCF that a company must gather in a year. If it is Class I and IIa medical device. How it is related to sale of the device.

    • @EasyMedicalDevice
      @EasyMedicalDevice  2 года назад +1

      Hi Riya, you have to define that per your knowledge of the product. You have to estimate your sales, then the number of surveys your will ask and number of people that will answer. So even if you say you will ask 100 surveys maybe only 30 people will answer. So always plan more than what you need in reality. But if you sell 100 units and get only 3 answers this will not be really significative. There is no magic number but helena Quie on a podcast said 50 is a good number of feedback.