Bug Fixes Documentation List#


Document Section

IEC 62304, Chapter 9



This list is used to document the evaluation and implementation of all bug fixes according to the company’s change management process.

Documentation of Bug Fixes#

Evaluation Categories

Bug ID




Bug Description

Hovering over button should display info box but doesn’t

Users do not understand how to use text field

Occurrence Date and Time



Corrective Action

Display of information when hovering

Renaming text field

Preventive Action

Added test scenario #T123 (link file)

Added usability test scenario #U123 (link file)

Affected Software Requirement

#REQ192 “Display user information (…)”

#REQ193 “Provide field to document information (…”

Corresponding Implementation Ticket
(optional, e.g. Github Pull Request)



Corresponding Test Documentation
(e.g. System Test ID #121)



Test Completed (When / By Whom)

2021-04-15 by John Doe

2021-04-15 by John Doe

Affected Risk Documentation


Risk ID #369 “User does not understand XYZ”

Preliminary Incident Assessment by MDSO

No incident

No incident

Preliminary Significance Assessment by QMO

Not significant

Not significant

Release Date of Updated Software Version