What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You make sure a medical device was designed on purpose, proven to work, and that the proof is written down.
You run design controls — tracing inputs to outputs to verification, keeping the risk file current, and assembling the design history file. You hold the distinction between verification, that the device meets its specification, and validation, that it meets the user’s need in use; and you keep risk management running past launch, updating it from production and post-market information rather than closing it at approval.
You are learning to build an argument that survives years later: this design was controlled, and here is why we believe it is safe. The weak seam in most organisations is between design and post-market — the risk file is completed for approval and then frozen while the field tells a different story. Keeping it live is unglamorous and is the thing that makes the argument still true when someone reads it in five years.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Inside device design assurance, between R&D and the quality system, across the product lifecycle.
- User needs and design inputs from R&D and clinical
- The hazard analysis that scopes the risk controls
- Design transfer to manufacturing
- Regulatory submission of the design evidence
- Stated, testable design inputs
- Verification and validation results from engineering and test
- A maintained hazard analysis
- Regulatory Affairs (for submission content)
- Manufacturing (for a transferable design)
- Post-market (for the risk baseline)
- Requirements-to-verification traceability
- The completeness and coherence of the design history file
- Keeping the risk file current through design change
- Designing the device — R&D owns the design
- Approving the submission — Regulatory Affairs owns that
- The design owner and QA management
- Immediately, for a design change proceeding without risk assessment or verification
- Design review, verification and validation records
- Requirements traceability matrix
- Risk management file updates and the risk management report
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Medical Device Quality pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 820Quality Management System Regulation (QMSR) — 21 CFR Part 820FDA · last revised 2026-02-02
- ISO 13485:2016Medical Devices — Quality Management Systems — Requirements for Regulatory PurposesISO · last revised 2016-03-01
- ISO 14971:2019Medical Devices — Application of Risk Management to Medical DevicesISO · last revised 2019-12-01
- IEC 62304:2006+A1:2015Medical Device Software — Software Life Cycle ProcessesIEC · last revised 2015-06-01