01
Completeness check
Gaps and inconsistencies flagged before an expert opens the case. Completeness and readiness before formal review starts - not after.
Intake to decision inside CertHub. Completeness before formal review. Modelled 58-63% effort reduction per TD submission (process model, pilot validation ongoing). Human validates every mapping.
Assessment pipeline
Sterilizator 20A · Intake → review → decision
Completeness check
96% · 2 gaps
GSPR mapping
Awaiting validation
Named capabilities
Not a reviewer chat. Not a document reader. Not a certificate-issuing AI. A controlled review workflow on structured MDR and IVDR data - built with you on your schemas.
Gaps and inconsistencies flagged before an expert opens the case. Completeness and readiness before formal review starts - not after.
GSPR and Essential Principles mappings from structured TechDoc data. The co-pilot surfaces evidence; it does not decide. Not a generic LLM on PDFs.
Structured review cycles: findings tracked, queries targeted, progress visible. Experts judge. The system fetches.
Deviation or assessment reports with source-level traceability. Draft awaits reviewer sign-off. CertHub never issues a conformity decision.
Documentation is structured in the manufacturer source system before it reaches you. Not a TIC workflow bolted onto unstructured files.
What's inside
Evidence mapping moves upstream. Only change is re-reviewed. Five phases configured around your checklists, auditor codes, and report formats.
01 Capability
RIMS-integrated case creation, expert assignment, and client communication in one place.
Assessment scope
Sterilizator 20A · Scoping aligned before upload
Regulation
MDR (EU) 2017/745
Device class
Class IIb
Check type
TechDoc Compliance Check
Standards
ISO 14971 · ISO 13485 · IEC 62366
Scope locked after the 30-minute call — assessment stays precise from step one.
02 Capability
GSPR/EP compliance mappings auto-generated from the TechDoc in under an hour. Gaps flagged before an expert opens the case.
Document structuring
Sterilizator 20A · MDR Annex II
Drop the full technical file
03 Capability
Automated checks flag inconsistencies and trigger targeted resubmission requests.
Assessment review
Sterilizator 20A · MDR · Assessor workspace
48
AI mapped
31
Validated
6
Open queries
GSPR 1
Device description §4.2
GSPR 4
Risk management file · ISO 14971
GSPR 10.1
Clinical evaluation · CER ch.6
04 Capability
Orchestrated review cycles: requirement allocation, findings tracking, progress monitoring. Experts judge. The system fetches evidence.
Expert validation
Sterilizator 20A · Conformity Check · Regulatory expert
Risk acceptability policy
Possible NC — AFAP vs ALARP wording
Risk management plan
Missing review before release
Expert note
Checking clause language against MDR GSPR-2…
05 Capability
One-click deviation or assessment reports with full source-level traceability.
Conformity assessment
Sterilizator 20A · MDR Annex II / III · RC1
Risk acceptability policy
AFAP in the plan contradicts ALARP in the criteria — not MDR GSPR-2.
Risk management review
No formal review statement before release.
Trust
No training on customer data. EU-hosted (Germany/Frankfurt). Tenant isolation. Your checklists, configurations, and assessment scheme remain your IP. Details in the Trust Center.
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Next step
Talk through backlog, reviewer capacity, and how Auditor Co-Pilot fits your schemas.