About the SaMD Traceability Check
What this check is
18 questions across six areas of a SaMD team’s Jira and Confluence: full traceability, risk management, change management, AI and data traceability, connected engineering, and documentation and ownership. It takes about six minutes and needs no confidential product details.
Why it’s useful
- See which links from user need to verified test hold up today, and which depend on manual searching.
- Find the gaps a reviewer would ask about first, before your next submission or audit.
- Get a shared, plain-language picture your engineering and quality leads can agree on.
What happens next
- Your score and the state of each area show on screen right away, with no email needed.
- If you want the written breakdown, leave your details. You get a link to it, and Ewa sends you her personal feedback on your results.
- Book a free 45-minute review call with Ewa to go through your two weakest areas and what to fix first.
SaMD Traceability Check · Question 1 of 18 · Area 1 of 6: Full traceability
18 questions across 6 areas, about six minutes. Your score shows right away; no email needed to see it. Not sure about one? Pick "Not sure": it counts as not in place and we flag it.