SOPs ISO 13485 General
For a medical device in the pre-market stage, that is, in the final stages of design and development, we have recently started the QMS process. What are ways in which we can go back and document changes made in the design and development of the device? Going forward we will start a formal ECO process but for any changes that have occurred, we have been compiled a list but do we need to show how each change was assessed? Do we need to follow a formal process although this did not exist when changes were being made? How do we determine which changes need to be in the list? For example, we have thousands of software changes, do we document all?
This has been a bit difficult to navigate as the device is not yet licensed and it still under design and development.
Thank you immensely for any advice you can give.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Since you still do not have implemented a quality management system, you are in a position where you can decide to what extent you will record all changes. If there are too many changes, then definitively it can be exhausting to record all of them. In that case, you probably can record some milestones.
Documentation that covers the Design and development is good to implement even now before all other procedures because:
- they will guide you on how to prepare a design file to be completely in compliance with ISO 13485 requirements
- they will allow your organization to keep records for future similar projects, learn faster, avoid previous mistakes, and so on
For more information on how to manage changes in the design and development you can see the following article:
- How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
How did we in our ISO 13485:2016 Documentation toolkit prepare these records you can see on the following link:
- Design and Development File https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/
- Procedure for Design and Development https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/
- Change Review Record https://advisera.com/13485academy/documentation/change-review-record-iso-13485-2016/
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Nov 17, 2020