Implementing 13485 as a wire harness supplier

1. Does it make sense for us to implement 13485 as a wire harness supplier?

ISO 13485:2016 is a standard that is applicable to manufacturers of medical devices. If you are manufacturing an element (wire harness) that goes into the medical devices, that there is a reason to implement ISO 13485:2016. In new Medical device regulation, 2017/745 is stated that all entities that are involved in the lifetime of the medical device are supposed to have implemented a quality management system:

• EU MDR Article 1 Subject matter and scope, https://advisera.com/13485academy/mdr/subject-matter-and-scope/)

2. If so, does it make sense to prepare both satndards at the same time

Since both standards are quality management systems based on the ISO 9001:2008, it makes sense to make it at the same time.

For more information about ISO 13485:2016, the following articles can be helpful:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• ISO 13485 structure and requirements - https://advisera.com/13485academy/what-is-iso-13485/

On the following link you can find a preview of our ready to used documentation toolkit – ISO 13485:2016:

• ISO 13485:2016 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/

Hi,

  Thank you for the prompt reply.

Our problem is that at the moment we do not have any product related to a medical device nor medical device customer. So how is it possible to create a technical file for our product?

According to the ISO 13485:2016 requirement 4.2.3 Medical device file, here are the elements that you need to have:

• a general description of your product and labeling
• specification of the product
• description of how you manufacture the device, package, store, handling, and distribution<
• if there is any kind of measuring or monitoring procedure
• if there are instruction or any requirement for installation to another device
• if there is a possibility to service your part of the device, then you need a procedure for that

For more information, please see the following article:

• How to meet ISO 13485:2016 requirements for medical device files - https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/