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Regulatory workload keeps stacking
MDR, IVDR, EUDAMED, AI Act, and jurisdiction pathways compound every quarter. Manual processes do not scale with the portfolio.
CertHub is the AI-native compliance platform that connects MedTech manufacturers and Notified Bodies through structured regulatory data, intelligent automation, and certification workflows.
Why it matters
Regulatory experts lose time hunting for the right version, re-entering the same product data across documents, and double-checking for inconsistencies. Documents are no longer the right foundation for compliance. Data is. When your product, process, and regulatory information lives as structured data, technical documentation and QMS stop drifting apart. AI can take over the repetitive work reliably, and your expertise goes back to judgment: making decisions only an expert can make.
Regulatory professionals spend their time ensuring product compliance, not chasing versions and reconciling documents across disconnected systems.
Hundreds of interconnected files become one connected data foundation. AI assesses changes and flags gaps across it, while you review and decide.
One unified data model supports every product and jurisdiction, so each submission builds on the same consistent, traceable foundation.
The solution
CertHub's AI-native Compliance Platform runs on structured regulatory data, letting manufacturers create, manage, and maintain Technical Documentation and Quality Management Systems (QMS) within a single cloud-based solution.
As the only provider serving both manufacturers and Notified Bodies, CertHub acts as the digital bridge between regulatory stakeholders. Connecting compliance data, processes, and assessments across the certification lifecycle to enable more efficient certification outcomes, bringing safe medical innovations to market faster.
Product, process, and regulatory data in one governed model, so documentation and QMS stay aligned and inconsistencies are prevented at the source.
Both modules live in one platform, so regulatory requirements and quality processes stay connected instead of being maintained separately.
AI agents draft, cross-check, and flag gaps directly on your compliance data. Nothing is saved until you review, adjust, and approve.
The same structured model connects manufacturers and Notified Bodies: faster reviews, clearer evidence trails, more efficient certification.
The shift
At scale, regulatory execution is no longer a document problem. It is a coordination problem across products, evidence, standards, and jurisdictions, with real market-access risk attached.
MDR, IVDR, EUDAMED, AI Act, and jurisdiction pathways compound every quarter. Manual processes do not scale with the portfolio.
Senior RA and QA talent is scarce. Cross-referencing evidence across systems burns the wrong people on the wrong work.
TechDocs, QMS, risk, PMS, and clinical evidence sit across SharePoint, Polarion, Jira, and legacy DMS, without a single governed model.
General-purpose LLMs on unstructured files produce plausible, untraceable output. That is not a shortcut to audit-ready certification.
Where to start
Product detail lives on the pages behind these doors. This page gets you to the right conversation.
Notified Bodies review inside the same model. For Notified Bodies
Customer Stories
Whether you manage an established product portfolio or are building compliance from scratch, CertHub adapts to your starting point.
“Seeing all our regulatory information in one model is a big step forward. CertHub lets us focus on data quality instead of formatting dozens of documents.”
Stefan KieslingerHead of QM & RA, OPED
“The platform alone isn't enough either — you still need expert guidance to navigate a truly complex regulatory context. When you bring it all together, that is absolutely perfect.”
Mario RoserCo-Founder, Elixion Medical Device
“From CertHub we got already 70, 80 percent preset. We only had to tweak the last 20, 30 percent to fit our specific product.”
Stefan LeonhardtCo-Founder, Munich Medical DevicesProof
Real numbers from programmes running on CertHub, not projections.
faster to certification
medical products maintained
less repetitive regulatory work
How we work
Implementation follows a structured project plan with jointly defined success criteria for each milestone. Your team can run it self-administering, or Guided Services take over selected work packages. Either way, CertHub stays in the review and enablement sessions.
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We start from what you already have. Existing SOPs, QM lists, technical documentation, and templates transfer into the platform, with a delta and gap analysis showing what is missing before anything gets rebuilt.
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Your product portfolio structure, requirements catalogue, roles, and approval flows are configured around your daily reality, not a template you have to bend your processes to fit.
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We start with a core team and prove the setup on a real product, then onboard further key users up to your full user group, with training and IT integration along the way.
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With the model and templates proven, further technical documentation and submission templates migrate on the same pattern, without redesigning the setup each time.
Trust & security
German hosting, certified security, validated software lifecycle. Full posture in the Trust Center.
Next step
Book a demo to find the right path for your portfolio, or explore the platform to see the data model behind it.
