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Fast Track to Certification

AI-powered CE certification software for medical device manufacturers. Accelerate MDR/IVDR safety standards, accelerate risk assessment, and pass conformity audits faster.

MedTech and IVD startups & scale-ups

Problem

High costs, uncertainty and delays in bringing products to market

Solution

CertHub's Certification Assistant is your trusted guide from zero to submission. Our regulatory expertise is built directly into the software: the right templates, the right structure, the right questions, step by step. We give you the head start that changes everything; you fine-tune the rest.

More resources for what matters...

0%

less knowledge on regulatory strategy necessary

0K €

costs for initial certification saved

0 weeks

instead of 6 months

What's inside

Product Setup via Certification Assistant

Tell us about your device – from classification and intended use to software components, risk levels, and target users. Certhub will automatically configure the Knowledge Model and preload the correct templates, and set up your complete submission structure

Tailoring Content to your type of medical device

We tailor our solution to your medical device, not vice versa like with any other software. CertHub adapts to your medical device properties and regulatory path and adjusts the required documentation based on your medical device properties.

Interactive Content Generation

Chat with our smart regulatory AI to answer a few follow-up questions. Step-by-Step you fill content required for your TechDoc and QMS – from risk assessments to intended purpose statements and usability summaries.

Submission Package Creation

Once your documentation is complete and approved, CertHub assembles your full TechDoc submission package in one click, fully formatted, traceable, and aligned with MDR/IVDR requirements. Ready to download, ready to submit.

One solution paving the roadmap to success for your medical device

CertHub Fast Track to CE Certification flow diagram

Three Content Domains. Unified in CertHub.

MDR

MediPureTech

Traditional Medical Devices

Use Case

Comprehensive QMS and technical documentation for Class I-III medical devices, covering design controls, risk management, clinical evaluation, and regulatory submissions.

Regulations & Key Content

ISO 13485 QMS Templates, EU MDR Technical Documentation, Risk Management (ISO 14971), Usability Engineering (IEC 62366)

Business Impact

60% faster regulatory submissions, 40% reduction in regulatory review cycles

IVD

DxTech

In-Vitro Diagnostics

Use Case

Specialized content for IVD manufacturers including analytical and clinical performance studies, quality control, and IVDR-specific requirements.

Regulations & Key Content

ISO 13485 QMS Templates, IVDR Compliance Templates, Analytical & Clinical Performance Evaluation, Notified Body Submissions

Business Impact

50% reduction in IVDR transition costs, faster time-to-market for new diagnostics

SaMD

SoftiTech

Software as Medical Device

Use Case

Complete framework for SaMD development, including software lifecycle processes, cybersecurity, AI/ML validation, and digital health regulations.

Regulations & Key Content

ISO 13485 QMS Templates, IEC 62304 Software Lifecycle, AI Act Readiness, Cybersecurity (ISO/IEC 27001), MDCG 2019-11 SaMD Qualification

Business Impact

70% faster SaMD development cycles, future-proof AI Act readiness

We’ll walk you through...

Let's find out more about CertHub and see the Certification Assistant in action.

CE Marking & Certification, Frequently Asked Questions

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CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.

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