Evolving QMS system of home blood test kit

First, you need to define what is the classification of your product. Then you need to make technical documentation for the medical device requested by MDR 2017/745, and documentation for the quality management system, which is mostly done by ISO 13485:2016.

This documentation you can do by yourself, hiring a consultant, or by buying a documentation toolkit. Buying a documentation toolkit is the fastest way because there you have all the documents requested by the standard prepared and you only need to adjust it to your company, product, and processes. 

For more information, please see MDR Annex VIII – Classification rules: https://advisera.com/13485academy/mdr/classification-rules/

What is the content of the ISO 13485:2016 & MDR toolkit you can find on the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/ 

After you prepare all necessary documentation, you need to find a certification body for the certification according to the ISO 13485:2016. If your medical device is Class I, then it does not need to be certified by a Notified body. Class I medical devices need to be registered in the local agency for medical devices. If your medical device is a higher class (Is, Im, IIa, or Iib, III) than the certification process under the Notified body is required. 

For more information about the certification process, please see the following links:

• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• How to use ISO 13485 to get your devices approved for CE Marking - https://advisera.com/13485academy/blog/2017/10/12/how-to-use-iso-13485-to-get-your-devices-approved-for-ce-marking/
• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/