All-in-one
Product Compliance Platform

No more painful paper work to launch your MDR / IVDR medical products with our next-level Digital QMS and Technical Documentation solution leveraging latest AI technologies

Compliance is mandatory

Complexity is not.

CertHub is an award winning platform for Compliance solutions backed, trusted and used daily by +125 MedTech industry experts coming from 

Integrate your entire regulatory, compliance and quality efforts into CertHub to focus on value adding tasks and leave the rest to us

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Launch your products years earlier
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Become audit ready with the press of a button!
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Flexible Templates to keep your proven structure
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Minimize manual effort and focus on value-adding tasks

and Save with CertHub

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reduced time and cost for initial certification

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more efficient regulatory processes

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automation of continuous compliance

Real Impact Real Words

Hear from our customers!

Dr. med. Mario Roser
Sarah Wali
Christoph Sing
Yamen Mohisn
Dr. Stefan Leonhard

Dr. med. Mario Roser

Managing Director & CTO of Elixion Medical GmbH

Outstanding support, robust AI features and great usability. It's rare to find a product that really delivers and is a joy to work with. 

Our Products

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Digital Technical Documentation

Efficient Data Management: No more copy and pasting by maintaining all product information in one single source of truth.

Smart Document Creation: No more time waste by automatically aggregating content and format verification records, reducing time spent on regulatory documentation.

Audit-Ready with 1-Click: No more fear of audits by using standardized templates to generate audit-ready Technical Documents, and export them as PDFs with just a click.

Global Compliance Expansion: No more wait for entering into new markets by creating customized templates for various jurisdictions (e.g., MDR, FDA 510(k)) with your existing inputs, unlocking new markets with minimal effort.

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Digital QMS

Seamless Collaboration: Enable easy approvals with digital e-signatures, automatic notifications, reducing delays and keeping process moving.

Save Time: Automate task assignments and streamline workflows, allowing teams to focus on critical work.

Single Input Entry: Capture what you need and do the analytics directly by structuring collected data with a dynamic forms builder.

Reduce Errors: Eliminate missing data with pre-filled documentation and structured product information.

Aligned Teams: Seamlessly connect the different teams together by ensuring that operational teams actually use the content which are defined in the QMS.

Why do we do what we do?

Our aim is to enable our customers to provide the best possible treatment to our loved ones by helping them to overcome the regulatory burden in providing the best care through innovative products.

CertHub has customers ranging from software to hardware products with risk classes I, IIa, IIb and III with focus on SMEs

Bestes Startup im Gesundheitswesen 2024

Meet our  network of experts, advisors and supporters such as ...

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Dr. Stefan Leonhardt

CEO and Co-Founder Kumovis (3D Systems)

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Prof. Dr. Oliver Hayden

Head of Translatum & TUM Chair of Biomedical Electronics Academic Director MedTech, Venture Labs Healthcare

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Christoph Sing

Regulatory Affairs Manager HP Medizintechnik GmbH & MD at HP Med Consulting GmbH

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Dr. Benedikt Wiechers

Founder & CEO Ocumeda

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Dr. Michael Gschwandtner

Managing Director & Founder Evoleen

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Dr. Bernd Krämer

Head of QM & RA FRIZ Biochem GmbH

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Sebastian Koller

Executive Director Advanced Technology | Global Research & Development bei Karl Storz SE & Co. KG

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Stefan Klein

Freelance Auditor for multiple Notified Bodies, Medical Device Expert

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CertHub offers software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.

© CertHub 2024