Do I need iso 13485 for prosthetic liner manufacturing?

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:

• EU MDR Annex 13 – Procedure for custom made devices https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/ and
• EU MDR Annex 9 – Conformity assessment based on a quality management system and assessment of the technical documentation https://advisera.com/13485academy/mdr/conformity-assessment-based-on-a-quality-management-system-and-assessment-of-the-technical-documentation/

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

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• How to get ISO 13485 certified - https://advisera.com/13485academy/iso-13485-certification/
• Clause-by-clause explanation of ISO 13485:2016 - https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/