Questions About Technical Documentation
IEC 82304: How Is It Different From The IEC 62304?
IEC 82304
October 9, 2024
Formative vs. Summative Usability Testing – What’s The Difference?
IEC 62366
October 1, 2024
Manual Tests vs. Automated Tests For Medical Device Software
September 17, 2024
Can We Do Agile Development For Our Medical Device Software?
Agile Development
May 19, 2024
We’re In A Rush. Can We Automate Our Technical Documentation Completely?
ChatGPT
Confluence QMS
Jira QMS
May 17, 2024
What Is Clinical Evidence (MDR)?
April 11, 2024
What Is a Clinical Development Plan?
February 13, 2024
What’s the Minimum Number of Users for a Usability Test?
IEC 62366
September 7, 2023
What is a MDR UDI? Unraveling the Importance of Unique Device Identification
UDI
August 22, 2023
What is IFA?
UDI
August 9, 2023
What is a GS1? Shedding light on the UDI provider
UDI
August 9, 2023
Do We Need a User Manual for Our Software as a Medical Device?
Instructions for Use
November 5, 2021
How Do SemVer Versions Map to Significant Changes for a Medical Device?
July 27, 2020
Software as a Medical Device: What’s a Significant Change?
July 27, 2020
Machine Learning Software as a Medical Device: Can We Update Our Model?
AI
Machine Learning
July 27, 2020
Do We Have to Re-Do All Software System Tests After a Minor Change?
IEC 62304
July 26, 2020
Can We Use GitHub and Other SaaS For Our Software as a Medical Device?
IEC 62304
ISO 13485
Software Validation
July 26, 2020
Should You Automate Your Software Architecture Documentation?
IEC 62304
July 26, 2020
Do Auditors Read Your Code?
IEC 62304
July 24, 2020
Do You Need Video Cameras For User Testing?
IEC 62366
July 23, 2020
How to document SOUP for IEC 62304 compliance?
IEC 62304
OTS Software
SOUP
April 29, 2020