ISO 10993-1:2025 Gap Checklist
Use this practical checklist to pressure-test a legacy BEP, BER, or near-finished submission section before reviewer questions expose avoidable gaps.
Built for Legacy Files
Best when an older BEP or BER needs to be reviewed against current lifecycle and evidence expectations.
Practical Review Prompts
Includes checks for device representation, endpoints, waived tests, chemistry integration, and reviewer-facing clarity.
Useful Before Remediation
Helps internal teams decide whether the next step is light revision, targeted remediation, or a full rewrite.
A fast self-check before you spend time defending weak documentation
The checklist is built for teams reviewing older files, preparing for submission, or trying to understand whether a document is likely to survive reviewer scrutiny. It is not a substitute for project-specific advice, but it gives you a structured way to catch obvious gaps before they become expensive.
Best when you already have a draft
Use it on a BEP, BER, TRA, or summary section that already exists and needs a sharper review lens.
Best when timing matters
Useful before FDA submission, notified body response work, or internal sign-off on a near-finished package.
Best when the team needs triage
Helps distinguish between surface-level cleanup and deeper gaps in logic, evidence, or document framing.
Best when 2025 changes are unclear
Highlights where lifecycle framing, benefit-risk language, and chemistry linkage often need strengthening.
Request the Checklist
Fill in a few details and the checklist download will open on the thank-you page.
Best For
- Legacy BEP or BER updates
- Pre-submission quality checks
- FDA or notified body remediation planning
What Happens Next
- Download the editable checklist immediately after submit
- Use it internally on your current documentation package
- Move to the paid gap review if the file needs expert triage
Your next step will appear here.