Why Cleanroom Methods Are Critical in Software Development for Medical Devices
What is SOUP? – How to Handle Software of Unknown Provenance
Why Software Safety Classes Can Be Reduced Through Other Risk Control Measures
Responding to Affidavit Requests During FDA Inspections
Breaking News: FDA Issues CSA Guidance
What Makes a Company Trustworthy in the Eyes of the FDA
A $30 Monthly AI Investment: A Challenge for Personal Growth
The Fundamental Structure of FDA Inspections