Notified bodies are under pressure: rising numbers of applications, more complex regulatory requirements and scarce expert resources. This leads to long processing times, backlogs and weakens their reputation as reliable partners.
⏱️ Time
20+ hours for GSPR completeness check
🔄 Inefficiency
Searching through 800-page PDFs instead of finding the right information instantly.
📄 Frustration
Unstructured documentation - looking for the same requirements to documentation links 10 times.
Solution
Auditor Co-Pilot supports auditors in the structured preparation and review of conformity assessments for Manufacturers.
⏱️ Time
3 times faster review cycles
🔄 Efficiency
Instant mapping between requirements, checklist items and TechDoc Documentation of Manufacturer - a real audit-trail
📄 Joy
Assessing without manual searches and with full control with our human-in-the-loop Co-Pilot.
Measurable benefits – Faster assessments, more security
0%
Shorter assessment cycle thanks to automated preliminary checks and automatic report generation
0x
More assessments per auditor due to full focus on meaningful work
0%
Transparent audit trails for traceable decisions and explainability
What's inside
End-to-End integrated Workflow
Phase1: Assessment Setup
Time Savings: 4-6 hours
Phase 2: Document Review & Structuring
Time Savings: 30-45 hours
Phase 3: GSPR/Essential Principles Mapping
Time Savings: 40-60 hours
Phase 4: Findings & Queries
Time Savings: 20-30 hours
Phase 5: Report Generation
Time Savings: 25-35 hours
Manufacturer portal & AI support
Manufacturers simply upload their documents, while AI automatically checks for completeness and assigns the content to the relevant regulations.
Examination with Auditor-Co-Pilot
Experts remain in control, but are supported by the co-pilot in searching for and evaluating evidence – for faster, more informed decisions
Fully configurable
Import your own test schemas, define individual rules and use built-in workflows for revisions and resubmissions.
Frequently Asked Questions from Notified Bodies
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CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.