Episode 7: What happens when an FDA investigator asks for your validation evidence—are you ready, or scrambling? In this episode, QT9 Vice President Max Austin breaks down FDA and ISO 13485 software validation requirements in plain language. From risk-based validation to common misconceptions and real-world inspection scenarios, this conversation demystifies what “fit for intended use” truly means.
Learn how QT9’s developer-level validation supports life sciences and medical device companies, why risk assessments are essential, and how cloud-based QMS software can significantly reduce validation burden while keeping you compliant and audit-ready.
What this episode explores:
What FDA and ISO 13485 really expect from software validation
Validation vs. verification explained in practical terms
Why risk-based validation matters—and how to right-size your effort
How QT9 provides developer-level validation to support inspections
Common pitfalls that cause audit stress and how to avoid them
Watch now to understand validation the right way—and see how QT9 QMS helps you stay compliant, confident, and inspection-ready. Learn more at QT9 Software.
Tags & hashtags:
QT9 Software, QMS validation, FDA validation, ISO 13485, software validation, life sciences compliance, medical device QMS, risk-based validation, FDA inspections, cloud QMS, regulated manufacturing
#QT9 #QMS #FDACompliance #ISO13485 #SoftwareValidation #LifeSciences #MedicalDevices #QualityManagement #RegulatoryCompliance