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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Nov 17, 2020