Dear Anon, using the IMDRF ToC is a good approach. It however does not align with e.g. the eSTAR format used in the US nowadays.
I advise to use the Design History File (or Design and development file, ISO 13485, clause 7.3.10) as the starting point. Such a file contains all design and development relevant documentation, obsolete and current. The DHF / Design File contains the majority of the documentation required per regulatory region. Per regulatory region you create a Table of Contents which points (without revision number!) to documents in the DHF/Design File. At any given moment you can create a Submission/Technical File. You can also create a Submission/Technical File at a date in the past.
The advantage is that the Submission/Technical File can be tweaked per regulatory region (different ToC's) and at any given date is correct and up-to-date.
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Peter Reijntjes
Consultant Regulatory & Quality Affairs Medical Devices
Heteren
Netherlands
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Original Message:
Sent: 12-Apr-2024 09:57
From: Anonymous Member
Subject: Technical Documentation Organization
This message was posted by a user wishing to remain anonymous
Yes, that's my approach, too. It's still a lot of work, but keeping it organized per the IMDRF ToC reduces the mental effort.
Original Message:
Sent: 11-Apr-2024 12:50
From: Anonymous Member
Subject: Technical Documentation Organization
This message was posted by a user wishing to remain anonymous
Hello,
Currently, we have devices in the US, EU, Thailand, and Singapore. Each of these markets requires documentation organized in a different manner. For the short term I am building out each submission as its own set of documents. This is cumbersome and barely sustainable but sustainable nonetheless. However, as we grow we hope to submit to more countries and maintain current submissions. I thought it would be a good idea to move to using the IMDRF ToC. Then, when a submission needs to be made, I can pull from one source of truth rather than maintaining separate files for each submission.
From what I have laid out, is the centralized source of truth, the IMDRF ToC, a good way to manage technical documentation? Or do the differences in organization and specific documents for a particular country/region drive the need to maintain wholly separate files and organization of these documents? Perhaps there is another approach I have not envisioned. Please note that I am a one-man operation for Regulatory and Quality, like I imagine many of you are.
I look forward to everyone's input!