Product Requirement and Product Specification Are Not Synonyms

Most teams use these two interchangeably. Auditors do not. They are phase labels, not synonyms. The label tracks where the artifact sits in the design flow.

Most teams use these two interchangeably. Auditors do not.

They are phase labels, not synonyms. The label tracks where the artifact sits in the design flow.

On the input side, you have requirements.

21 CFR 820.30(c) called them design requirements.

ISO 13485 Section 7.3.3 calls them inputs relating to product requirements.

On the output side, you have specifications.

21 CFR 820.30(h) called them production specifications.

ISO 13485 Section 7.3.8 calls them final production specifications.

Same flow. Different phase. Different word.

Under the QMSR (Quality Management System Regulation), these requirements now flow through ISO 13485 by reference, but the phase logic is identical.

Here is the part people miss. The same artifact changes roles as it cascades.

The output specification at the system level becomes the input requirement at the subsystem level.

Output of layer N. Input of layer N plus one.

That is not a contradiction. It is the documented behavior of design controls, and the 1997 FDA Design Control Guidance says so directly.

If your traceability matrix swaps the terms at random, the inconsistency is the finding.

The fix is not a glossary. The fix is labeling every artifact by its phase position.

Win this argument before the audit by labeling correctly in your QMS (Quality Management System).

#MedicalDevices #DesignControls #QMSR #ISO13485 #FDA #MedTech