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Do I need iso 13485 for prosthetic liner manufacturing?

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Guest user Created:   Sep 08, 2020 Last commented:   Sep 10, 2020

Do I need iso 13485 for prosthetic liner manufacturing?

Do I need iso 13485 for prosthetic liner manufacturing?

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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 Sep 10, 2020

Yes, the prosthetic liner is a medical device so you need to have implemented ISO 13485:2016. Also, since the prosthetic liner is custom made device, then you need to prepare all necessary documentation as stated in the Medical device regulation MDR 2017/745, in:

For more information on ISO 13485, please see the following links:

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Sep 08, 2020

Sep 10, 2020