A structured AI assessment of your Technical Documentation or QMS. Every finding is validated by a regulatory expert, with gaps flagged and a prioritized remediation plan before a Notified Body sees your submission.
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.
Two checks
Both share the same five-step process. Choose the check that matches what you are preparing for, or run both.
Five steps, from scoping call to expert debrief.
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.
A 30-minute call to align on regulatory scope, applicable standards, and device type.
Makes sure the assessment is precise from the start.
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.
Share your QMS documents, Technical Documentation, and SOPs in any format.
No platform login and no setup required.
Drop .docx to import
CertHub's purpose-built AI runs structural and semantic checks across every applicable requirement.
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.
A regulatory expert validates every finding and filters out false positives.
Prepares a prioritized remediation plan with clear action items.
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…
You receive a full report: compliance score, gap list, remediation plan.
Followed by a debrief call to walk through what matters most.
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.
The report
Every finding validated by a regulatory expert. Not raw AI output.
Overall and per module, showing exactly where you stand against each requirement.
Every finding documented with the specific clause violated and the evidence gap identified.
The exact questions your Notified Body will ask, so you can prepare answers before the audit.
What to fix first, why it matters, and what evidence to produce.
Next step
Book a demo to walk through TechDoc, QMS, or both. Or open the platform if you want the full product path.
