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ISO 13485 & EU MDR
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Guest user Created:   Dec 10, 2019 Last commented:   Dec 11, 2019

Customer feedback

ISO 13485 & EU MDR

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Dec 11, 2019

For European market there is a guidelines from European comission on the following link 

https://ec.europa.eu/growth/content/draft-guide-distribution-medical-devices-including-vitro-diagnostic-medical-devices_en

For American market, please follow guidelines from FDA on the following link

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

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