ISO 13485 · Basic · 14 min lesson

Clause 7.3 - design and development: phases, deliverables and traceability

ISO 13485:2016 clauses 7.3.1 to 7.3.10; EU MDR Annex I and Annex II; FDA QMSR (21 CFR part 820)

What you will learn

Describe the stages and deliverables of clause 7.3, from planning in 7.3.2 to the design and development file in 7.3.10.
Tell design verification from design validation and explain what representative product, review and transfer require.
Build a traceability chain from user need to validation, handle design changes, and spot a design record that fails an audit.

Clause 7.3 runs from planning (7.3.2) through inputs, outputs, review, verification, validation, transfer and change control to the design and development file (7.3.10).
Inputs must be complete, unambiguous, verifiable and approved; outputs must meet inputs and carry acceptance criteria.
Verification asks whether outputs meet inputs; validation asks whether the device meets user needs and intended use, on representative product.
Traceability from need to input to output to verification and validation is planned in 7.3.2 and shown in the file.
Design changes are reviewed, verified, validated as appropriate and approved before implementation, including effect on delivered product and risk.

Corvane's validation was done on ten hand built prototype pumps assembled by the design engineers. Production units use a different moulded canister.

What is the main concern under clause 7.3.7?

The units may not be representative product, and no rationale for the choice is recorded.

Correct. Clause 7.3.7 requires validation on representative product, such as initial production units, with the rationale recorded.

None, since prototypes always count as representative product.

Not quite. Clause 7.3.7 names production units, batches or equivalents, and prototypes with a different canister are not equivalent.

Only the number of units, which must be at least 30.

Not quite. Clause 7.3.7 sets no fixed number; it asks for a statistical rationale where appropriate.

The validation must be done by a notified body.

Not quite. Clause 7.3.7 places validation on the organisation, not on an external body.

design input: A requirement used as a basis for design and development, covering function, performance, usability, safety and regulation (ISO 13485 clause 7.3.3).
design output: Result of design and development that meets the inputs and gives information for purchasing, production and service (ISO 13485 clause 7.3.4).
design verification: Confirmation that design outputs meet design inputs, performed to documented plans (ISO 13485 clause 7.3.6).
design validation: Confirmation that the device meets requirements for the specified application or intended use, on representative product (ISO 13485 clause 7.3.7).
design transfer: Ensuring outputs are verified as suitable for manufacturing and production capability meets requirements (ISO 13485 clause 7.3.8).
traceability matrix: A table linking needs, inputs, outputs, verification and validation so each requirement can be followed end to end (ISO 13485 clause 7.3.2).
design and development file: The file for each device type or family holding or referencing the records that show conformity to design requirements and changes (ISO 13485 clause 7.3.10).

The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

Illustrative example. Educational only, not legal advice.