In medical device development, compliance isn’t just a regulatory hurdle — it’s a critical safeguard for patient safety and product integrity. One of the foundational elements in ISO 13485:2016 is design and development verification (clause 7.3.6), a stage that ensures our devices are built right — even before we validate that they’re the right devices.What Is Design Verification?
Clause 7.3.6 of ISO 13485:2016 states:
“Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.”
In practical terms, verification answers the question:
“Did we build the product correctly, according to our specifications?”
This is typically achieved through:
- Engineering calculations
- Simulations and bench testing
- Inspections
- Software unit tests
- Design reviews
A strong verification plan should define:
- The methods used (e.g., stress tests, code inspection)
- The acceptance criteria
- Any statistical techniques and a rationale for the sample size
Verification vs. Validation: Not just semantics
| Verification | Validation |
| Did we build the product right? | Did we build the right product? |
| Confirms design outputs match inputs | Confirms the product meets intended use |
| Typically performed via inspections, tests, simulations | Typically includes clinical or usability evaluations |
| Often done at component or subsystem level | Done on final, representative product |
This distinction can summarized :
Verification: Does it meet the criteria?
Validation: Does it really work as intended when used by the people it’s designed for?
Examples of verification
- Sterilization process: EO residual testing per ISO 11135
- Packaging: Drop tests, seal strength
- Software: Static code analysis, unit testing
- Mechanical components: FEA modeling, fatigue testing
Even design transfer (clause 7.3.8) requires verification to ensure outputs are suitable for manufacturing.
Why this matters ?
Design verification:
- Catches errors early, avoiding downstream failures
- Reduces cost by resolving issues before validation or production
- Is often required under regulations (EU MDR Annex II, FDA 21 CFR 820.30)
When verification is weak or absent, validation may fail — and by that point, it’s expensive and risky to fix.
Verification may not get much attention, but it plays a crucial role in making sure your design matches the original requirements — step by step, no surprises.
It’s not just about ticking a box — it’s about building confidence in your design before you commit to the final product and fulfilling ISO 13485 requirement.