Validation under actual or simulated use conditions on representative product, with results documented — 820.30(g) intent preserved.
Clinical or performance evaluation explicitly required; interface validation for connected devices; risk management no longer confined to the validation phase.
Clinical evaluation records and usability testing documentation — validation packages that end at bench testing without user-context evidence are cited.
Maps to
QMSR / ISO 13485: §820.30(g) Design validation.
ISO 13485: §7.3.7 Design and development validation
ISO 14971: §8 Evaluation of overall residual risk
Requirement text
Design validation shall confirm the resulting product meets requirements for the specified application or intended use.
Why this clause exists
Verification confirms that design outputs meet design inputs — that the device was built as specified. Validation answers the distinct and harder question: does the device, as built to specification, actually fulfill the needs of the intended user in actual conditions of use? The two activities are complementary and cannot substitute for each other. A device can pass every verification test — all dimensions within tolerance, all materials meeting specification — and still fail to meet user needs if the inputs themselves did not adequately capture those needs. Validation closes this gap by requiring testing under defined operating conditions representative of actual use, using production-representative units rather than prototypes, because the production process itself can affect performance. The requirement for clinical evaluation or usability testing where applicable reflects regulators' recognition that the risk of a mismatch between intended and actual use is highest when human factors — how real users interact with the device under real conditions — determine whether the device achieves its clinical purpose. The crosswalk to ISO 14971:2019 § 8 (evaluation of overall residual risk) is intentional: validation data is the primary input for confirming that the overall residual risk of the device as a system is acceptable. A device that cannot be validated against its intended use cannot have its overall residual risk evaluated, which means the fundamental safety determination the design process is meant to produce cannot be made.
What changed
§820.30(g) — Part 820 (legacy)
"Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF."
§7.3.7 — ISO 13485:2016 (current)
"Design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size. Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded (see 4.2.5). As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer. If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), validation shall include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced. Validation shall be completed prior to release for use of the product to the customer. Records of the results and conclusion of validation and necessary actions shall be maintained (see 4.2.4 and 4.2.5)."
Δ Adds a mandatory validation plan with acceptance criteria, requires clinical/performance evaluation per regulatory requirements, and mandates recording the rationale for representative product selection.
Common gaps (what we see in audits)
- No documented validation plan prior to execution — ISO 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 — ISO 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 — Design 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 — Validation 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 — ISO 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.