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Design Controls

Planning​

MO 169 requires the organisation to plan and control the design and development of devices. The design plan must identify:

  • Design and development stages
  • Required reviews, verifications, and validations at each stage
  • Responsibilities and authorities for design and development

Design inputs and outputs​

Design inputs — the functional, performance, safety, and regulatory requirements that form the basis of the device design — must be documented, reviewed, and approved. Incomplete or ambiguous inputs are a leading cause of design problems.

Design outputs — specifications, drawings, manufacturing instructions, and other documents that define the finished device — must be documented in a form that enables verification against inputs.

Design review, verification, and validation​

Design review — systematic, documented evaluation at planned stages to assess whether design results meet requirements. Participants must include representatives from all relevant functions.

Design verification — confirmation (through testing, inspection, or analysis) that design outputs meet design inputs.

Design validation — confirmation that the device consistently meets user needs and intended uses under simulated or actual use conditions. For devices with complex interfaces, usability engineering (human factors) testing is part of validation.

Design transfer​

The process of transferring the design from development to manufacturing must be controlled. Manufacturing specifications, work instructions, and inspection criteria must be established and verified before commercial production begins.

Design changes​

All design changes must be reviewed, verified, and validated before implementation and must be approved before implementation. Changes to the approved design must be evaluated against the criteria for Ichibu Henko (partial change approval) under the PMD Act before implementation.