FDA & ISO 13485 Design Outputs and the DMR
Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record…” [Emphasis added by ComplianceAcuity]. This definition is also compatible with the corresponding requirements in ISO 13485:2016 clause 7.3.4.
Here are some pointers to help derive, manage, and maintain design outputs relative to the DMR and DHF:
A. The realization of design outputs is an iterative effort:
The realization of design outputs is an iterative effort done as follows:
- Translate design inputs into final engineering specifications and solutions comprehensively meeting all of the targeted parameters and characteristics itemized in the design inputs.
- Define and document design output in objective terms allowing an adequate evaluation of conformance to design input requirements. Do this by defining design outputs in objective, tangible terms, and by using a trace matrix (see step B. below).
- Make reference to acceptance criteria. (Note: The acceptance criteria and test methods for the final design output are ultimately established and vetted during design verification and thereafter translated into the final Device Master Record in the form of final product, labeling, packaging, and process specifications.)
- Identify and distinguish the design outputs that are essential for the proper functioning of the device (i.e., those that will ultimately make up the Device Master Record, as well as those derived from the risk-control design inputs conceived via risk analysis to mitigate unacceptable risk).
- Document and approve probationary design output as needed (prior to final verification/validation) via AR (Advance Release) numeric revisions.
- Initiate trial builds as necessary to adjust the product or process design, test equipment, facilities, etc., as needed to meet design input requirements.
- Progressively update AR versions of design outputs as the design evolves toward the final design alpha-rev outputs and final/release.
B. Ultimately, ensure that design outputs in all cases include proper traceability:
Ultimately, ensure that design outputs in all cases include proper traceability, meaning backward traceability to the originating design inputs, and forward to corresponding verification and validation. Accomplish this by recording the design outputs in the ‘Output’ column of a trace matrix.