ISO 10993-1:2025 Gap Checklist
Start with a 10-minute red-flag scan, then mark 89 device-specific review prompts and convert the findings into a controlled action plan.
Key service strengths
10-Minute First Pass
Screen 12 foundation-level red flags before committing time to the full file review.
89 Markable Prompts
Record Clear, Weak, Missing, or N/A directly in the PDF across nine review sections.
Results You Can Act On
Summarize gaps, separate priority from workload, and assign owners, evidence needs, and target dates.
10-minute red-flag scan
Mark whether each red flag is Present, Absent, or Uncertain. Present and Uncertain items identify sections to review in the full PDF; they do not create a pass/fail score.
No email is needed for this scan. Answers stay in this tab, are not saved or sent, and are not included in analytics. This is the 12-item first pass, not the full 89-prompt review.
From MDA-FR-001, Version 3.1, issued 13 August 2026.
The browser scan needs JavaScript. You can still request the original interactive PDF and use its page 2 scan.
0 of 12 answered
Preliminary red-flag summary
MedDev Advisory · MDA-FR-001 v3.1 · 12-item scan from page 2 · Issued 13 August 2026
Preliminary summary of your answers only. Present and Uncertain items need follow-up; Uncertain is not a confirmed defect. Even if all items are Absent, this scan does not establish conformity, biological safety or submission readiness. It does not replace the full 89-prompt review.
Where to continue in the full PDF
Use these references in your Version 3.1 working copy. Confirm the evidence for each item, then record an owner, evidence need and next action.
Choose your next step
Get the full 89-prompt PDF to continue the controlled review. Read the companion guide for context.
If you want a device-specific review, explore the gap-analysis service.
Recorded answers
One file, reviewed from quick scan to action plan
Version 3.1 is a structured screening workflow for an existing BEP, BER, TRA, chemistry report, or submission section. It helps you locate documentation vulnerabilities and decide what needs internal correction, targeted remediation, or qualified review. It does not certify biological safety or regulatory readiness.
If the screening identifies material gaps or conflicting evidence, the founder-led ISO 10993-1:2025 gap analysis provides a device-specific review and prioritized remediation path.
Quick red-flag scan
Twelve Present / Absent / Uncertain checks route you to the sections that need deeper review.
Nine-section full review
Review device identity, exposure, endpoint logic, legacy data, chemistry, changes, EU MDR, risk management, and clarity.
Transparent triage
The disclosed workload formula ranks remediation effort only; P1, P2, and P3 priority is assessed separately.
Controlled next actions
Use the results sheet and eight-row action register to assign evidence, owners, deadlines, and approval needs.
Get Version 3.1
Enter your email and the download opens immediately on the next page.
Best For
- Legacy BEP or BER review
- Pre-submission document triage
- Reviewer-response remediation planning
What Happens Next
- Download the 17-page interactive PDF
- Save a working copy and review one controlled file
- Use the result to choose internal or expert remediation
Your next step will appear here.