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Evolving QMS system of home blood test kit

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Guest user Created:   Jun 15, 2020 Last commented:   Jun 16, 2020

Evolving QMS system of home blood test kit

We need to evolve a QMS system of our home blood test kit, which included a specimen collection device. We need to produce a Declaration of Conformity and be CE ASAP. What is the quickest way to go about this?

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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 Jun 16, 2020

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:

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Jun 15, 2020

Jun 16, 2020