Requirement of ISO 13485 for manufacturing of semi-finished product

Yes, you can make QMS according to ISO 13485 and get certified. The complete production process for the final medical device needs to be manufactured under the requirements of ISO 13485:2016. According to the Medical device regulation (MDR 2017/745), to ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation, all manufacturers should have a quality management system. The quality management system shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices.

Complete list of necessary documentation you can find in the following links: 

• ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
• List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/ 

For more information, you can read the following articles

• Plan-Do-Check-Act in the ISO 13485 standard  - https://advisera.com/13485academy/knowledgebase/plan-do-check-act-in-the-iso-13485-standard/

• How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

• How to manage the Quality Manual according to ISO 13485:2016 requirements https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/

Also, if you are in a hurry to implement your QMS, or if you want to avoid consultancy costs, perhaps our documentation toolkit could be useful: https://advisera.com/13485academy/iso-13485-documentation-toolkit/ 

I have manufactured a standard prosthetic liner. I know I need ISO 13485. My questions is: Do I need ISO 10993?

Also do I need to have the liner tested for durability? If so, which organisation can test it for me?

Yes, you need to prove that your prosthetic liner is biocompatible with the human body. To prove it, you need to perform certain tests according to the ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Guidance on which tests you need to perform you can find in Annex A of this standard. The number and scope of tests will depend on the length of contact of the medical device with the skin, the type of contact, and the like. 

Considering the test for durability, you need to prove how long your product is stable when using in compliance with instructions of use. This includes, for example: how long the prosthesis is worn during the day, whether it is properly maintained, whether it is left somewhere in the strong sun or not.

As for testing, I don’t know what part of the world you’re in. If you are in Europe, there is a whole chain of Eurofins labs that do different tests, so you can ask them.