From 8f1f1d29d8a8b25886881cc4b54a1adf24b8cc5a Mon Sep 17 00:00:00 2001 From: Markus Thielen Date: Tue, 31 Jan 2023 22:57:05 +0100 Subject: [PATCH] drafts started --- DIN EN 62304/software-development-maintenance-plan.md | 6 ++++++ DIN EN 62304/teschd.md | 2 -- General documents/instructions-for-use.md | 6 ++++-- General documents/intended-use.md | 7 +++++++ 4 files changed, 17 insertions(+), 4 deletions(-) delete mode 100644 DIN EN 62304/teschd.md diff --git a/DIN EN 62304/software-development-maintenance-plan.md b/DIN EN 62304/software-development-maintenance-plan.md index 24f89f6..54ec5a8 100644 --- a/DIN EN 62304/software-development-maintenance-plan.md +++ b/DIN EN 62304/software-development-maintenance-plan.md @@ -1,5 +1,11 @@ # Software Development and Maintenance Plan +**Document Change History** + +| Version | Date | Author | Change Comment | +|---------|------------|----------------|----------------| +| 0.1 | 2023-02-01 | Markus Thielen | Draft | + > This document is related to your product. You somehow need to associate it with it. The easiest way would be > to just put all product-related documents into a folder in your QMS so that the association is > clear. Alternatively, you could mention the related product and version here, but then you'd have to update diff --git a/DIN EN 62304/teschd.md b/DIN EN 62304/teschd.md deleted file mode 100644 index 090680a..0000000 --- a/DIN EN 62304/teschd.md +++ /dev/null @@ -1,2 +0,0 @@ -# Regulation - diff --git a/General documents/instructions-for-use.md b/General documents/instructions-for-use.md index 4351cfa..13d9ae4 100644 --- a/General documents/instructions-for-use.md +++ b/General documents/instructions-for-use.md @@ -4,9 +4,11 @@ # User Manual [enter Product Name] -Version: [enter content] -Date: [enter content] +**Document Change History** +| Version | Date | Author | Change Comment | +| ------- | ---------- | -------------- | -------------- | +| 0.1 | 2023-02-01 | Markus Thielen | Draft | [Placeholder Company Address] Email: [enter content] diff --git a/General documents/intended-use.md b/General documents/intended-use.md index 4fd277d..c185629 100644 --- a/General documents/intended-use.md +++ b/General documents/intended-use.md @@ -1,5 +1,12 @@ # Intended Use +**Document Change History** + +| Version | Date | Author | Change Comment | +|---------|------------|----------------|----------------| +| 0.1 | 2023-02-01 | Markus Thielen | Draft | + + ## Mapping of Requirements to Document Sections > Only relevant if you're aiming for MDD (and not MDR) compliance: