On September 24, 2025, the FDA released its final guidance “Computer Software Assurance for Production and Quality System Software.”
What’s new?
- The guidance introduces a risk-based approach to ensuring that production and quality system software is reliable and fit for its intended use.
- It replaces (in part) Section 6 of the long-standing “General Principles of Software Validation.”
- The goal: avoid over-testing and over-documentation of low-risk functions, while focusing resources where the impact is critical.
- Encourages agile practices, iterative testing, continuous monitoring, and performance-based assurance.
Why it matters for medical device and regulated quality environments?
- Less bureaucracy, more focus – Efforts are directed where they truly matter.
- Faster upgrades and changes – The lighter approach allows smoother implementations and system updates.
- Regulatory robustness – Risk-based decisions must be well-justified, documented, and auditable.
- Alignment with modern manufacturing and digital transformation – The guidance reflects broader trends such as Industry 4.0, critical thinking in validation, and regulated digital innovation.
How MDRu can support your organization?
- Gap analysis of regulated software systems against the new FDA expectations
- Risk-based assessment and assurance strategy design
- Test planning, monitoring, and validated maintenance approaches
- Team training on CSA and regulatory “critical thinking” mindset
If you want to understand how this new guidance can be applied to your business, MDRu is ready to help.
Access the doc here.