Template: Bug Fixes Documentation List

Sven Piechottka IEC 62304 Templates Published June 09, 2022

Template Download

This is a free template, provided by OpenRegulatory.
If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you're using a different QMS software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom, don't re-use this for commercial purposes).

Lost In Regulation? We're here to help.

Unsure how to get started and how to get your EU MDR medical device certified?
We've already helped 100+ companies with their MDR compliance.
Take a look at our services and book a free 30-minute consulting call.

Template Preview

Bug Fixes Documentation List

Regulations Document Section
IEC 62304, Chapter 9 All

Summary

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 #B01 #B02 (...)
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 01-04-2021 16-03-2021
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) #T123 #T132
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 2021-04-16 2021-04-16

Template Copyright openregulatory.com. See template
license
.

Please don't remove this notice even if you've modified contents of this template.

Sven Piechottka avatar

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.