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Know exactly what's wrong with your 10993 package before the auditor does.

Upload your biological evaluation documentation. Receive a structured gap report — every section scored against ISO 10993-1:2025 requirements, with specific remediation steps. A fraction of the cost of traditional consulting.

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gap-report.pdf
72
Readiness Score
3 areas need attention
BEP Completeness PASS
Chemical Characterization (10993-18) PASS
Toxicological Risk Assessment (10993-17) FLAG
Risk Management Integration FAIL
2025 Version Compliance FLAG
Foreseeable Misuse Coverage FAIL
The Problem
Your 10993 package has gaps you haven't found yet.

ISO 10993-1:2025 introduced new requirements that most existing documentation doesn't address. Notified bodies are already auditing against the updated standard — and rejections cost months.

$2k–8k
Typical cost of a single gap analysis from an outside consultant
3–6 mo
Average delay from a notified body rejection requiring revised biocompatibility documentation
12+
Distinct ISO 10993 sub-standards that must be addressed across the full package
How It Works
From upload to remediation plan in 24 hours.
01
Upload your package
Upload your BER, BEP, or full 10993 documentation as PDF or Word files.
02
Select evaluation type
New submission, 2018-to-2025 transition review, or legacy compliance check.
03
Every section is evaluated
Your documents are evaluated against a comprehensive requirements framework built from regulatory domain expertise and aligned with notified body expectations.
04
Receive your gap report
Section-by-section scoring with plain language explanations and specific remediation steps, delivered within 24 hours. Export as PDF.
Full Series Coverage
Every part of the 10993 series. One evaluation.

Each area receives a Pass, Flag, or Fail status — with a plain language explanation of why notified bodies challenge it, and what to fix.

1
Biological Evaluation Plan
Strategy justification, endpoint selection, and rationale completeness.
1
BER Structure & Narrative
Overall coherence against ISO 10993-1:2025 requirements.
18
Chemical Characterization
Material identification, extractable/leachable coverage per Part 18.
5
Cytotoxicity
Test documentation and result interpretation per Part 5.
10
Sensitization & Irritation
Protocol and endpoint documentation per Part 10.
3
Genotoxicity
Risk justification and test selection rationale per Part 3.
17
Toxicological Risk Assessment
TRA methodology and tolerable exposure calculations per Part 17.
→
ISO 14971 Risk Integration
Risk management file cross-referencing — severity, probability, uncertainty.
New in 2025
→
Foreseeable Misuse
Documentation of misuse scenarios and their biological safety implications.
New in 2025
Δ
2018 → 2025 Version Gap Flagging
Identifies elements compliant with 2018 but deficient under the 2025 standard.
Transition Support
Built For
Designed for the people who do this work every day.
Consultants

Independent RA professionals

Managing multiple client submissions? Run every package through a structured check before delivery. Consultant mode lets you manage all clients from one dashboard.

Startups

Device company RA leads

Small regulatory teams don't always have the bandwidth for a full internal gap review. Get notified body-level scrutiny on your documentation before it ships.

CROs

Contract research organizations

Handling regulatory submissions as a service? Integrate structured quality checks into your workflow. Enterprise tier includes multi-user access and API integration.

Pricing
A fraction of the $2,000–$8,000 that other gap analysis services cost.

Traditional consultant-led gap analysis runs $2,000–$8,000 per engagement. Our tool delivers the same depth of first-pass analysis at a fraction of the cost — with per-submission and monthly subscription options available.

We're finalizing pricing ahead of launch. Join the waitlist for early access and priority pricing, or reach out directly to discuss your needs.

Join Waitlist Request Pricing
Security & Trust
Your documentation is handled with care.

We know what's in these files. Enterprise-grade infrastructure with a security posture built for regulated industries.

🔒
Encryption in transit and at rest
🗑
Documents deleted after processing
🇪🇺
GDPR compliant — DPA available
☁
Enterprise cloud hosting (Azure / AWS)
📋
SOC 2 on roadmap

Disclaimer: This tool is a pre-submission gap checker designed to complement your regulatory expertise — not replace it. All output should be validated by a qualified regulatory affairs professional. This is not a compliance guarantee.

Early Access
Be the first to evaluate your 10993 package.

We're onboarding early users now. Join the waitlist and we'll reach out when your access is ready.

No spam. We'll only email you about access and product updates.

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FAQ
Common questions.
Does this replace my regulatory consultant?
No. This is a pre-flight checker — it catches gaps, missing sections, and non-compliant justifications before your consultant or auditor does. Think of it as a structured first-pass review that saves your expert reviewers time and catches the obvious issues early.
Which version of ISO 10993-1 does it evaluate against?
Primarily the 2025 standard, with awareness of the 2018-to-2025 delta. You can select your evaluation type — new submission, transition review, or legacy check — and the analysis adjusts accordingly.
What file formats do you accept?
PDF and Word (.docx) files. You can upload individual documents or a complete package.
How is my documentation handled?
Your files are encrypted in transit and at rest, evaluated through our secure analysis process, and deleted after your report is delivered. We do not retain your documentation. Enterprise cloud hosting with GDPR compliance and a DPA available on request.
How much does it cost?
We offer both per-submission and monthly subscription options at a fraction of the $2,000–$8,000 that traditional consultant-led gap analysis costs. We're finalizing pricing ahead of launch — join the waitlist or reach out to us directly to discuss your needs and get priority pricing.
How long does the evaluation take?
You'll receive your gap report within 24 hours of uploading your documentation. Each report includes section-by-section scoring, plain language explanations, and specific remediation steps.
Can it check my Clinical Evaluation Report too?
A CER gap scanner module is on our expansion roadmap. The initial launch focuses on the full ISO 10993 biological evaluation series.
Get in Touch
Have a question? Want to discuss pricing?

Whether you're exploring the tool for your team or have a question about coverage, we'd like to hear from you.

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