Fast Track to Certification

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. All our regulatory expertise is built into the software – tailored to your needs, guiding you step-by-step with confidence in fully digital solution with dedicated MedTech Content – we handle it for you so you can concentrate on building your business.

More ressources 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. We'll configure the proper Knowledge Model, 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 automatically 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

We automatically assemble your complete TechDoc package – fully formatted, traceable, and aligned with MDR/IVDR requirements. Your submission-ready files are available for instant download.

One solution paving the roadmap to success for your medical device

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

IVDR Compliance Templates, Performance Evaluation, Quality Control Procedures, 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

IEC 62304 Software Lifecycle, AI Act Compliance, Cybersecurity (ISO 14155), Digital Health Pathways

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.