9 Design validation not recorded
Design validation confirms the finished device meets the user need and its intended use, on representative product, before release. This user need has no validation recorded in the paste.
- the test
- a user need or stakeholder requirement with a blank validation cell, where the paste has a validation column or ISO 13485 is ticked
- the question
- Which validation covers this user need, on which units, and where is its record?
- asked of
- the design quality lead
- columns it reads
- Validation and Level
The clauses behind it, by standard
each shown when you tick its standardThe clause text
Validation of design and development follows planned, documented arrangements and confirms that the finished product can satisfy what its intended use or specified application demands. The organization documents validation plans giving methods, acceptance criteria and, where appropriate, statistical techniques with the reasoning for the sample size. Validation is done on representative product, such as initial production units or batches or their equivalents, and the reasons for that choice are recorded. Clinical or performance evaluations of the device form part of validation, carried out as the relevant regulatory requirements demand; a device supplied for such an evaluation does not count as released to the customer. Where the intended use needs the device to connect or interface with other devices, validation must show the requirements are satisfied in that connected state. Validation must be finished before the product is released to the customer for use, and records of its results, conclusions and any actions are kept.
Held text: ISO 13485:2016, our statement of the clause, not the instrument verbatim.
what an assessor asks to see Validation plans with methods, acceptance criteria and sample-size rationale; Rationale for the representative product used; Clinical evaluation or performance evaluation records meeting regulatory requirements; Validation reports completed before release for use; Connected-use validation where applicable
where it usually breaks Validation performed on prototypes rather than representative production units without a recorded rationale; Clinical evaluation treated as a regulatory-affairs deliverable disconnected from design validation; Product released for use before validation is closed
Section 820.10 establishes the substantive QMS requirements by incorporating ISO 13485:2016 SECTIONS 4 THROUGH 8 in full. Manufacturers must implement: ISO 13485:2016 SECTION 4 General QMS requirements + documentation (Quality Manual + Medical Device File + control of documents + records); SECTION 5 Management responsibility + customer focus + quality policy + planning + responsibility / authority / communication + management review; SECTION 6 Resource management (provision of resources + human resources + infrastructure + work environment + contamination control); SECTION 7 Product realization (planning + customer-related + design and development - the medical-device 'design controls' parallel + purchasing + production and service provision + control of monitoring + measuring equipment); SECTION 8 Measurement + analysis + improvement (monitoring + measurement + control of nonconforming product + analysis of data + improvement - including CAPA Sections 8.5.2 + 8.5.3). NB: ยง820.10 also clarifies that ISO 13485:2016 internal-audit + management-review requirements (Sections 8.2.4 + 5.6) apply to the QMSR.
Held text: 21 CFR Part 820 (QMSR), our statement of the clause, not the instrument verbatim.
what an assessor asks to see ISO 13485 Section 4-8 compliance file; Internal audit programme + records; Management review records + frequency; Cross-reference matrix between QMSR + ISO 13485 + EU MDR/IVDR + FDA Part 11
where it usually breaks ISO 13485 implemented in parts without full Section 4-8 coverage; Internal audit infrequent or scope-limited; Management review absent + meeting minutes incomplete