What is CertHub's Compliance Platform?

A structured data model for MedTech product and process data. From that model you generate technical documentation, QMS records, and global submissions, so every filing is built the same way.

How is it different from a document DMS?

A DMS stores files. CertHub stores the facts those files are made from: intended purpose, risks, evidence, and process data in one governed model. The file is generated from approved data and templates.

Who is the Compliance Platform for?

Manufacturers at every stage: growing portfolios (SME and mid-market), global operations (enterprise), and first certification (startups without an in-house RA team). Notified Bodies review inside the same model.

How do I get started?

Book a demo to walk through how your technical documentation and QMS would work on the platform. Many teams also start with a Conformity Check before a larger commitment.

One structured data model behind everything you submit.

CertHub's Compliance Platform holds your product data once, then generates your technical documentation, your QMS, and your global submissions from it. Every filing is built the same way, every time.

Book a demo Explore technical documentation

CertHub

Product database

Sterilizator 20A · MDR

Knowledge Units

Device Description

Intended Use

Use Environment

Risk Management

Hazards

Risk Controls

Clinical Evaluation

Knowledge Topic

Intended Use

Low-temperature H₂O₂ sterilization of reusable surgical instruments in healthcare facilities.

Structured data

What changes

Stop maintaining the same facts twice.

Documents display data. They should not be where the data lives.

01

Hold product data once

Intended purpose, risks, evidence, and process data live in one governed model. Not in Word, Excel, and folders.

02

Generate the file from that model

Approved product data plus approved templates become your technical documentation, QMS records, and submissions.

03

Keep it current when something changes

Change a device, supplier, or requirement, and see every linked object it touches before you approve.

One structured data model. Templates for EU MDR and FDA.

Ten core domains stay on. Switch MDR, IVDR, or SaMD and the outer packages follow. FDA 510(k) sits in the model next to EU templates.

Always on

10 core domains

QMS ISO 13485

Product Dev

Risk ISO 14971

Usability 62366

GSPR Checklist

Device & RA

Info Supplied

Manufacturing

CertHub Brain

EUDAMED Export

Added for MDR

Clinical Eval

Suppliers

Biocompatibility

Elec. & Mech.

PMS

PMCF

FDA 510(k)

Sterilization

Enhance

We ship templates for EU MDR and FDA. The same model is how you stand up other jurisdictions.

Built on your product data

Your product data is the foundation.
Everything here is built on it.

Intended purpose, risks, evidence, and process data are entered and approved once. Technical documentation, quality management, global submissions, and AI agents all draw on that foundation. Nothing is re-entered or maintained twice.

Technical Documentation

Submission-ready files generated from approved product data and approved templates, versioned and change-controlled as your product evolves.

Explore technical documentation

Quality Management

Your ISO 13485 QMS (SOPs, forms, approvals, and audit records) held in the same data model as your technical documentation.

Explore quality management

Global Submissions

Every jurisdiction generated from one source and tracked in one place, from EU MDR/IVDR to FDA 510(k) and beyond.

Explore global submissions

AI agents

Agents on validated EU-hosted data: CertHub agents or yours via MCP. The human always remains in control.

Explore our AI Agents

One validated core. Agents around it. Markets from the same data.

TechDoc and QMS stay audit-ready. AI agents keep them current. Product data flows in, then one dossier fans out to every market.

Validated core — TechDoc and QMS in one place

Who it's for

Which of these is you?

The platform is the same. Where you start and how you get set up is not.

SME & Mid Market

Growing portfolios

Company profile: Established manufacturer with one or more approved products and a growing footprint across markets.
Typical trigger: Expansion into new markets, a growing documentation load, or an audit finding.
Why CertHub: Scalable compliance management with greater efficiency and improved audit readiness.

For growing portfolios

Enterprise

Global operations

Company profile: Large, multinational manufacturer operating globally with a complex product portfolio.
Typical trigger: Enterprise-wide digital transformation or regulatory harmonization across regions.
Why CertHub: Global standardization, governance, and operational excellence.

For global operations

Startups

First certification

Company profile: Early-stage manufacturer preparing a first product for market, without an in-house regulatory team.
Typical trigger: CE certification preparation or an upcoming funding milestone.
Why CertHub: Faster time to market.

For first certification

Notified Bodies review inside the same model. For Notified Bodies

Proof

One model. Data quality over document formatting.

Manufacturers use CertHub to get products certified and keep them compliant as they change, from a first CE mark to growing portfolios. Built by regulatory experts, developed and hosted in Germany.

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.

Read the OPED story

Frequently asked questions

Next step

Walk through the data model on your product.

See how your TechDoc, QMS, and submissions would draw on one structured source, not parallel files.