Supplier's Category: All Medical Device Validation: V&V services for ISO 13485 compliance
Medical device validation provides verification and validation (V&V) services for ISO 13485 compliance — confirming a device meets its design requirements and performs safely as intended, as part of the formal quality system medical device makers must maintain. It’s tightly coupled to design controls, not a standalone test.
V&V work has to trace directly back to documented design inputs, so a lab unfamiliar with medical device design controls will produce results that don’t satisfy an auditor.
- Confirm experience specifically with ISO 13485 design control documentation, not just general test execution
- Ask whether they can support your specific regulatory pathway (FDA, EU MDR) documentation requirements
- Check whether human factors/usability validation is offered alongside technical V&V, if your device needs it
Related terms: ISO 13485 quality system, design verification, design validation, human factors/usability testing, risk management (ISO 14971), design history file, FDA 510(k) test support, EU MDR conformity assessment
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Where validation sits in the design control process
V&V isn’t a single event — it’s woven through the design control process from requirements definition through final release.
Typical sequence
- Verification testing confirms the device meets each documented design input
- Validation testing confirms the device meets user needs in realistic use conditions
- Results feed the design history file supporting regulatory submission