AI-supported 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 MDR requirements, MDCG guidelines, and relevant standards in minutes — not weeks.

Many manufacturers, by contrast, still rely on manual checklists, individual reviews, and the feeling that there may be a blind spot somewhere. This asymmetry creates uncertainty: Will the auditor raise findings that I could have avoided in advance?

Results in a short time

Our AI quickly delivers a structured gap report. You gain time for remediation before the audit costs you time and nerves.

Review from the auditor’s perspective

We review against the requirements that notified bodies also focus on: MDR Annex II/III, MDCG guidelines, and relevant standards.

AI and expert review when needed

AI systematically identifies gaps and inconsistencies. In the appropriate packages, experienced experts add regulatory assessment and prioritization.

Clear prioritization

You do not receive an overwhelming collection of materials, but prioritized findings, concrete actions, and a clear basis for decision-making.

Extended support in the premium package

In the premium package, we support you beyond the initial review with re-reviews and ongoing assistance throughout further audit preparation.

Regulatory monitoring

New guidelines, updated standards, changing expectations: we analyze which changes are relevant for your documentation.

• ✓AI analysis against MDR Annex II/III and relevant MDCG guidelines
• ✓Gap report with prioritized findings
• ✓Action list for structured remediation
• ✓Dashboard and PDF export
• ✓Delivery within 48 hours on business days*

• ✓Everything included in the TD Blitz Check
• ✓Validation and weighting of findings by senior experts
• ✓Results call with concrete recommendations
• ✓Remediation guide for prioritized findings
• ✓Perspective from experienced audit-focused reviewers
• ✓Delivery within 5 business days*

• ✓Everything included in the TD Expert Review
• ✓Two re-reviews after your remediation
• ✓Audit readiness assessment
• ✓Monitoring of regulatory changes
• ✓Dedicated point of contact

How can AI review our technical documentation in a short time when experts need weeks?

Our AI is tailored to regulatory requirements for medical devices and reviews documentation in parallel against relevant requirements. This quickly creates a systematic overview. In the appropriate packages, experts complement this analysis with regulatory assessment and prioritization.

Does the AI replace the human expert?

No. The AI performs the systematic review for completeness, consistency, and alignment with regulatory requirements. In the appropriate packages, the expert adds assessment, prioritization, and concrete recommendations for action.

Is my documentation secure with you?

Yes. All data is processed on ISO 27001-certified infrastructure in the EU. NDAs are, of course, possible. Archiving or deletion is agreed with you on a project-specific basis.

Which parts of the TD are reviewed?

By default, we review the relevant elements in accordance with MDR Annex II and III, including product description, intended purpose, classification, risk management, clinical evaluation, verification and validation, labeling, as well as PMS/PMCF. We define the exact scope during the initial consultation.

How does the initial consultation work?

In 30 minutes, we clarify your product, classification, the status of your TD, your timeline, and which package makes sense for your situation. Short, concrete, and without obligation.

Can I also book individual components separately?

Yes. The TD Blitz Check (€ 9,000) and the TD Expert Review (€ 20,000) are available separately. The TD Audit Shield (€ 40,000) is the complete package with re-reviews and additional support.

We have multiple products. Are there volume options?

Yes. For manufacturers with multiple products, we offer structured portfolio solutions with recurring reviews, monitoring, and a dedicated point of contact.