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For class III medical devices, looking for guidance to understand what are the responsibilities of a distributor having a full process, from storage and delivery to clinical use activities such as user training and proctoring. this will help me to write a proper quality agreement.
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Kristina Zvonar Brkić
Dec 11, 2019
For European market there is a guidelines from European comission on the following link
For American market, please follow guidelines from FDA on the following link
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Dec 10, 2019
Dec 11, 2019
Dec 11, 2019