Customer Stories

Regulatory requirements look different at every stage.

Whether you manage an established product portfolio or are building compliance from scratch, CertHub adapts to your starting point.

Established products. Growing regulatory complexity.

Established manufacturers face a specific problem: documentation and QMS processes that don't scale as products and regulations multiply. Technical files spread across systems, audit prep that consumes the team, MDR transitions that never seem to close. CertHub centralizes everything into one platform. Audit-ready, always.

Established MDR Video

OPED

Orthopedic manufacturer. MDR-compliant technical documentation for 6 product variants in one platform.

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Established ISO 13485

ISAR-M

Surgical monitoring device. QMS migration from legacy system to ISO 13485, completed in 6 weeks.

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The CertHub platform in practice

For established manufacturers: structured technical documentation and QMS tools that handle multi-product portfolios without the agency overhead.

Technical Documentation

One source of truth.

Version-controlled and traceable documentation across your full product portfolio, automated. Always audit-ready.

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AI Conformity Checker

Find the gaps before the notified body does.

Upload your technical documentation. The AI validates readiness against MDR and IVDR requirements and identifies every gap before your audit.

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eQMS

Your team keeps working. The QMS stays audit-ready.

Move your legacy QMS to ISO 13485-compliant processes. 60% faster regulatory submissions, zero process disruption.

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Early-stage teams building compliance from zero.

Most MedTech startups hit the same wall: they know what they are building, but have no QA or RA team, no budget for a consultant, and no clear path to CE mark. CertHub gives them the structure to submit their first technical file in weeks, without external help.

Startup MDR Video

Elixion

Electrosurgical devices. CE marking under MDR with full technical documentation package.

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Startup MDR Video

Munich Medical Devices

Class IIb implantable devices. Full MDR compliance documentation across the product line.

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Startup IVDR

BugSense

TU Munich spinoff. Point-of-care UTI diagnostics. Certification readiness 75% faster, €205K in regulatory costs saved.

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Startup IVDR

Urikon

Urine diagnostic IVD device. IVDR pathway, QMS, and technical documentation completed in 4 weeks.

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The CertHub platform in practice

For MedTech startups: fast-track CE and IVDR certification tools built for first submissions, from technical documentation to QMS setup.

Fast Track to CE

From idea to CE mark. 70% faster.

The certification assistant guides you step-by-step through MDR and IVDR. Adaptive configuration, no QA/RA team required yet. The assistant handles the regulatory steps. You build the product.

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Technical Documentation

Documentation. Push of a button.

Convert research data into IVDR-compliant technical files automatically. The AI Auto-Extractor structures your studies into audit-ready technical files.

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eQMS

Build your QMS from zero.

Pre-configured for IVD and MDR. SOPs and training records structured from day one, ready for your first ISO 13485 audit. No consultant required.

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Your next step in compliance.

Tell us where you are in the regulatory process. We'll show you the clearest path forward.

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