Conformity Checker & Gap Analysis

CertHub's Conformity Checker & Gap Analysis is an AI-assisted tool designed for MedTech SMEs and startups preparing for global quality management system (QMS) audits, technical documentation submissions, and regulatory gap analysis under MDR and IVDR frameworks. The tool addresses a core challenge in medical device compliance: hidden documentation gaps and incomplete records that cause submission delays and escalating costs.

CertHub supports teams from initial gap analysis through to submission readiness, combining live completeness tracking with automated pre-audit and submission checks. The goal is to ensure documentation is produced accurately and is defensible during regulatory review, with visibility into compliance status for specific jurisdictions such as the EU (MDR/IVDR) and FDA.

Core Features

• Gap Analysis Assistant: Identifies documentation gaps upfront and supports planning to meet MDR/IVDR standards before submission deadlines. Provides immediate insight into the quality and gaps present in existing documents.
• Completeness & Progress Tracker: Monitors missing and outdated content across every individual submission or dossier, giving teams a clear picture of the current status of their QMS and technical documentation for a given jurisdiction.
• QMS Ready-for-Audit Checker: Simulates an auditor's perspective by applying both structural and semantic checks to QMS documentation. Results can be combined with a management review process to assess audit readiness at any point in time.
• TechDoc Submission Checker: Checks technical documentation for content and completeness against general safety and performance requirements, aligned with notified body expectations. Automatically generates an evaluation report summarising findings.

Intended Workflow

1. Upload or connect existing QMS and technical documentation within CertHub.
2. Run the Gap Analysis Assistant to surface missing or non-conforming documentation areas relative to MDR/IVDR requirements.
3. Use the Completeness & Progress Tracker to monitor remediation progress across all active dossiers.
4. Apply the QMS Ready-for-Audit Checker to validate structural and semantic compliance from an auditor's perspective.
5. Run the TechDoc Submission Checker to verify content against safety and performance requirements and generate an evaluation report prior to submission.

CertHub is a software platform focused on the MedTech industry, offering tools across technical documentation, QMS, design control, UDI management, and EUDAMED in addition to the Conformity Checker & Gap Analysis module. The platform is available in English and German.