Maps to
QMSR / ISO 13485: §820.30(g)
ISO 13485: §7.3.7
Requirement text
Design validation shall confirm the resulting product meets requirements for the specified application or intended use.
What changed
Part 820.30(g) required design validation to ensure the device conformed to defined user needs and intended uses. Validation had to include testing under actual or simulated use conditions, be performed on initial production units or equivalents, and include software validation and risk analysis where appropriate. The Part 820 requirement for risk analysis was specifically tied to validation.
ISO 13485:2016 clause 7.3.7 requires design validation to confirm that the resulting product meets the requirements for the specified application or intended use. Validation must be performed in accordance with planned and documented arrangements, and must be completed prior to delivery or implementation of the medical device. Where intended use requires the device to be connected to or interface with other device(s), validation must include confirmation of performance when connected.
A significant structural shift is that under ISO 13485, risk management is no longer confined to the validation phase — it is integrated throughout design controls via 7.3.3 (inputs). However, ISO 13485 7.3.7 retains the expectation that validation demonstrates the product is safe for its intended use, which inherently requires confirmation that risk controls are effective in real-world conditions.
ISO 13485 also explicitly requires that validation include clinical evaluation or performance evaluation in accordance with applicable regulatory requirements. This adds specificity beyond Part 820's 'actual or simulated use conditions.' For software-as-a-medical-device and combination products, the validation requirements under QMSR are more clearly articulated through the ISO framework's references to IEC 62366 (usability engineering) and IEC 62304 (software lifecycle).
The requirement that validation use 'representative product' (rather than Part 820's 'initial production units or equivalents') is slightly broader, allowing validation on units representative of production output without requiring literal first-article units in all cases.
Atomic constraints
- •Validation must be performed under defined operating conditions
- •Validation must confirm product meets intended use
- •Clinical evaluation or usability testing must be included where applicable
- •Validation results must be recorded
- •Validation must be performed in accordance with planned and documented arrangements, meaning a validation plan must be documented and approved before validation activities begin.
- •Validation must be performed using representative samples — either initial production units or product representative of initial production output — not prototype or hand-built units unless equivalence to production is formally justified.
- •When the intended use requires the device to connect to or interface with other devices, validation must include confirmation of performance in the connected configuration.
- •Validation must address clinical evaluation or performance evaluation in accordance with applicable regulatory requirements for the intended use.
- •Validation must confirm that the device meets user needs and intended use in the conditions and environment expected during actual use.
- •Validation results, including the method used, the date, and the individual(s) performing validation, must be recorded.
Common gaps
No documented validation plan prior to execution
majorISO 13485 7.3.7 requires validation 'in accordance with planned and documented arrangements.' Similar to verification, many companies execute validation testing without a pre-approved validation plan that defines intended use conditions, acceptance criteria, sample requirements, and statistical rationale.
Validation does not include clinical evaluation or usability testing
majorISO 13485 7.3.7 requires validation to include clinical evaluation or performance evaluation per applicable regulatory requirements, and to address intended use including user interaction. Many Part 820-era validation protocols focus on bench testing and do not include formal usability evaluation per IEC 62366 or clinical evidence review.
Validation on non-representative product
majorDesign validation was performed on R&D prototypes rather than initial production units or their equivalents. ISO 13485 and QMSR require validation on representative product.
Weak usability validation
majorValidation focused on technical specs but failed to perform 'summative usability testing' for critical user tasks. ISO 13485 §7.3.7 requires validation for 'intended use.'
Interconnected device validation not addressed
moderateISO 13485 7.3.7 requires that when the device interfaces with other devices, validation must include confirmation of performance in the connected configuration. Many legacy validations test the device in isolation without validating interoperability with connected systems.
Evidence signals
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FILE_EXISTS
(Validation.*Protocol|Validation.*Report|Clinical.*Evaluation|Usability)
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CONTENT_MATCH
Does this document describe design validation activities, clinical evaluation, or usability testing for intended use?
Audit defense
Design validation for [your product] is documented in [your document ID]. Validation was performed under defined operating conditions to confirm the device meets its intended use, with clinical evaluation and usability testing included per QMSR 820.30(g).