MDR gap analysis: how to read a gap report before NB

I most often see 40+ gap lists with no owner and no date. The report sits in SharePoint while the file that goes to NB still has a hole in GSPR or risk management.

Gap check vs NB audit

A gap report is an internal tool: it shows where documentation diverges from MDR and what to close first. It does not replace a formal NB audit and does not “issue CE”.

How to read priorities

• High: missing or conflicting critical areas (e.g. GSPR, risk, clinical/eval, IFU) — close before formal NB engagement
• Medium: inconsistencies NB will likely probe — dated remediation plan
• Low: editorial / TOC polish — do not block the critical path

What to do with the report

1. Assign an owner to each gap (QA / RA / R&D)
2. Separate blockers from nice-to-haves before NB kick-off
3. Do not mix remediation with “hope NB will not notice”

Fixed-price service: MDR Gap Check.