AI-Powered Review of Your Technical Documentation

Authorities and Notified Bodies are already using AI systems to systematically review Technical Documentation. They identify gaps, inconsistencies, and deviations from regulatory requirements in minutes — not weeks.

Your RA team, on the other hand, is still working with manual checklists and the nagging feeling that a blind spot might be lurking somewhere. This asymmetry creates uncertainty: Will the auditor raise findings that we could have avoided?

Results in 24 Hours

While traditional reviews take weeks, our AI delivers the first complete gap report within a single day. You gain time for revisions — instead of losing it to waiting.

On Par with Auditors

Our AI reviews against the same standards as Notified Body systems: MDR Annex II/III, current MDCG guidelines, harmonized standards. You see your documentation through the auditor's eyes — before they do.

AI and Expert Judgment

Artificial intelligence finds gaps systematically. But only an experienced regulatory expert can assess how significant a finding is and which resolution approach is pragmatic. With us, you get both.

Clear Actionable Guidance

You won't receive an 80-page report that leaves your team on their own. Our report prioritizes every finding and provides concrete remediation paths — sorted by criticality using a traffic light system.

Up to 12 Months Guarantee

In the Premium package, we stand behind our review: if findings are identified in areas we reviewed during an audit, we perform the follow-up review at no additional cost. Your risk becomes our risk.

Regulatory Monitoring

Requirements change. New MDCG guidelines, updated standards — our AI monitors these changes and analyzes their impact on your documentation. So you won't be caught off guard by updates.

• ✓Complete AI analysis against MDR Annex II/III and MDCG guidelines
• ✓Gap report with traffic light system (critical / relevant / nice-to-have)
• ✓Prioritized action list
• ✓Interactive dashboard + PDF export
• ✓Delivery within 24 hours

• ✓Everything from the TD Quick Check
• ✓Senior expert validates and weights all AI findings
• ✓60-minute results call with actionable recommendations
• ✓Revision guide for each finding
• ✓Notified Body perspective from audit-experienced reviewers
• ✓Delivery within 5 business days

• ✓Everything from the TD Expert Review
• ✓Two re-reviews after your revisions (AI and expert)
• ✓Johner Audit Readiness Certificate
• ✓12-month audit guarantee with free follow-up review
• ✓Quarterly AI monitoring scan for regulatory changes
• ✓Dedicated point of contact

How can an AI review our Technical Documentation in 24 hours when experts need weeks for the same task?

Our AI has been specifically trained on regulatory requirements for medical devices — MDR annexes, MDCG guidelines, harmonized standards, and Notified Body expectations. It reviews in parallel, not sequentially. This means every section is simultaneously checked against all relevant requirements. The senior expert then uses the AI report as a foundation and focuses on what only a human can do: contextual assessment, regulatory judgment, and evaluation of your specific product situation.

Does the AI replace the human expert?

No — and that's precisely the point. The AI handles the systematic completeness check. The expert handles the assessment: How significant is this finding? How will an auditor react? What is the most pragmatic remediation path? Only the combination of both delivers the level of quality we need to back our guarantee.

Is my documentation safe with you?

Absolutely. All data is processed on ISO 27001-certified infrastructure within the EU. We naturally sign NDAs. The documentation is archived or deleted after project completion according to your instructions. We will clarify the details during the initial call.

What exactly does the 12-month guarantee cover?

The guarantee applies to the sections of your TD that we reviewed and confirmed as audit-ready. If a Notified Body raises a finding in exactly those areas, we perform the follow-up review and 3 hours of expert consultation at no charge. The guarantee does not cover areas that were substantially modified by you after our review without a subsequent re-review.

Which parts of the TD are reviewed?

By default, we review all elements according to MDR Annex II and III — including: product description & specification, intended purpose & classification, risk management file, clinical evaluation, verification & validation, biocompatibility, software documentation (if applicable), labeling & IFU, PMS/PMCF plan. The exact scope is defined during the initial call based on your product.

How does the initial call work?

30 minutes, free of charge and without obligation. We will discuss: your product, its classification, the current status of your TD, your audit timeline, and whether the TD Audit Shield is the right format for your situation. No sales pitch — just an honest assessment.

Can I also book individual components?

Yes. Our TD Quick Check (AI report only, €9,000) and the TD Expert Review (AI + expert without guarantee, €20,000) are available separately. The TD Audit Shield is our all-inclusive package for maximum security.

We have multiple products. Are there volume options?

Yes. For portfolio manufacturers, we offer our TD Compliance Subscription — with annual reviews, continuous monitoring, and a dedicated point of contact for your entire portfolio. Bring it up during the initial call.