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-paste. Keep all product information in one single source of truth.

Smart Document Creation: No more time waste. Automatically aggregate content and format verification records to cut down time on regulatory docs.

Audit-Ready with 1-Click: No more audit fear. Generate audit-ready Technical Docs from templates and export them as PDFs in one click.

Global Compliance Expansion: No more delays. CertHub reuses your existing inputs to generate tailored templates for MDR, FDA 510(k), and more—unlocking new markets with minimal effort.

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Digital QMS

Seamless Collaboration: Enable smooth approvals. Digital signatures and automatic notifications reduce delays and keep processes moving.

Save Time: Automate tasks. Streamline workflows so teams can focus on what really matters.

Single Input Entry: Structure collected data with dynamic forms to capture exactly what you need and analyze it instantly.

Reduce Errors: No more missing data. Pre-filled docs and structured info ensure completeness.

Aligned Teams: Seamlessly connect teams. Ensure operational teams use the content defined in the QMS.

Why do we do what we do?

We help our customers deliver the best care by easing the regulatory burden behind innovative treatments.

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

Frequently Asked Questions

Is CertHub already in use and passed Audits?

Yes daily. We are very proud that CertHub has numerous successful partnerships and customers ranging from large medium sized companies to startups who used our systems successfully in Audits and are enjoying how streamlined their regulatory processes are using the platform.

Does CertHub provide audit support?

Yes, CertHub’s expert Auditor team offers assistance with audit preparation and execution, ensuring you meet all necessary requirements. We are in close exchange with several notified bodies.

Who is benefiting from using CertHub?

CertHub is tailored to the needs of Small-and-Medium Sized companies, Scale-Ups and StartUps (Our speciality is: IVD, SaMD and hardware medical devices). It is the right fit for companies who want more than a quick-and-dirty high maintenance solution - A future-proof affordable technology companion which growths with the growing needs of the company (e.g. full-adaptability, customisability, continuous compliance, AI Use Cases, etc.). The people who are using CertHub are Quality Managers, Regulatory Affairs Specialists, Founders, Technical Engineers, Managing Directors, Department Heads, and Consultants working in the medical device industry.

How quickly can I achieve results with CertHub?

Depending on the complexity of your project, CertHub can help you create compliant documentation ranging from few days to few months instead of years.

How much time and cost can I save with CertHub?

By automating document creation and regulatory tasks, CertHub helps companies reduce the time to market by years and significantly lowers costs associated with compliance and quality processes. For some of our customers the time and cost savings were up to 60%, comparing the overall costs for compliance and quality with our fair prices we offer an outstanding value for money and Return of Investment. Not even considering the revenue business potential of market approvals in several Jurisdictions (Europe, USA, Brasil, etc.) TL;DR The costs of non-quality are always higher and high quality is THE business advantage in MedTech

How easy is it to use CertHub for someone without deep regulatory knowledge?

CertHub provides intuitive workflows, pre-built templates, and guided steps to Get-Started easy as well as a great network of regulatory experts for all disciplines. Depending on the complexity of your medical device often customers also grow their own competences on the fly or get additional external support.

Which standards & regulatory frameworks does CertHub cover?

The majority of our customers are using the following frameworks for MedTech compliance: *MDR* (Medical Device Regulation – EU 2017/745) and *IVDR* (In Vitro Diagnostic Regulation – EU 2017/746) USA: *Premarket Notification 510(k) Path +* US FDA 21 CFR Including the latest standards to streamline your compliance process (e.g. ISO 13485, ISO 14971, IEC 62304, and IEC 62366) In addition, thanks to our very modular and adaptive system, our customers are very successfully using our system daily also for related standards such as ISO 9001, ISO 14001, ISO 50001 and regulatory frameworks such as EU AI Act for a real All-in-One Product Compliance solution covering your integrated Quality Management Systems and Documentation records.

Can I customize CertHub to fit my company's needs?

Yes, what makes our system unique and future proof is that the CertHub can be tailored to your companies specific needs and offers adaptable workflows and templates, very much different to some “hard-coded” systems out limiting the users to pre-defined configurations.

Can I export my data?

Yes, you can export your data anytime with a single click, ensuring flexibility and control over your documentation

How secure is my data with CertHub?

CertHub prioritizes data protection and security in everything we do. Your data is handled confidentially, stored securely, and can be exported at any time. Reach out to us, we have an information package regarding Data Protection & IT Security ready for you.

What happens to my data if I cancel my subscription?

You can export your data when canceling your subscription in a easy systematic and machine-reading way, our philosophy is we want to keep you happy on the entire journey from On-Boarding to Off-Boarding, no exceptions.

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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