Question 1

Is CertHub Brain GDPR-compliant and where is data stored?

Accepted Answer

Yes. CertHub Brain processes all data exclusively on EU servers. Your documents, queries, and AI responses never leave the European Union. Every interaction is automatically logged and traceable, creating a built-in audit trail for regulatory oversight. The system is designed to meet the data governance requirements of MedTech companies operating under EU MDR (Regulation 2017/745) and GDPR. No third-party data sharing agreement is required; Brain is included as part of the CertHub platform.

Question 2

Is CertHub already in use and passed Audits?

Accepted Answer

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.

Question 3

Does CertHub provide audit support?

Accepted Answer

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.

Question 4

Who is benefiting from using CertHub?

Accepted Answer

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.

Question 5

How quickly can I achieve results with CertHub?

Accepted Answer

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

Question 6

How much time and cost can I save with CertHub?

Accepted Answer

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

Question 7

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

Accepted Answer

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.

Question 8

What is CertHub Brain?

Accepted Answer

CertHub Brain is an AI compliance assistant built for MedTech companies. Unlike general-purpose AI tools, it connects directly to your live electronic Technical Documentation (eTD) and Quality Management System (QMS). It does not rely on uploaded files, so every answer is current, traceable, and grounded in your actual regulatory data. You can ask plain-language questions such as "Which MDR Annex II requirements are missing verification evidence?" and receive a structured, audit-ready response in seconds. CertHub Brain runs on EU servers, is GDPR-compliant, and is included in existing CertHub plans.

Question 9

Which standards & regulatory frameworks does CertHub cover?

Accepted Answer

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.

Question 10

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

Accepted Answer

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.

Question 11

Can I export my data?

Accepted Answer

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

Question 12

How secure is my data with CertHub?

Accepted Answer

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.

Question 13

What happens to my data if I cancel my subscription?

Accepted Answer

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.

Question 14

Does CertHub support EUDAMED registration and UDI management?

Accepted Answer

Yes. CertHub automates the entire EUDAMED submission workflow, from extracting UDI data out of your existing documents to generating schema-validated XML files ready for upload. You don't need XML knowledge or IT involvement. Our system manages Basic UDI-DI and UDI-DI records, supports multi-variant and multi-packaging hierarchies, and keeps your data in sync across Technical Documentation, QMS, labels, and EUDAMED

Question 15

Do I need to build my own EUDAMED XML solution or use my ERP?

Accepted Answer

Most ERPs and in-house tools are not designed for EUDAMED's validation rules, schema updates, or UDI hierarchies. CertHub is a validated, purpose-built solution that handles EUDAMED-specific requirements automatically, including schema changes, country-specific mandatory fields, and GxP-compliant data management. No build effort, no ongoing maintenance on your side.

Your Trusted Compliance Companion

Streamline compliance and regulatory work with Certhub – focus on what matters, we handle the rest.

1-Click Documentation - eTD AND eQMS

Fast Track to Certification and QMS ISO 13485

QM Audit Checker

Conformity & Gap Checker

1-Click Documentation - eTD AND eQMS

Fast Track to Certification and QMS ISO 13485

QM Audit Checker

Conformity & Gap Checker

Proven Success - Save with CertHub

Real Impact Real Words

Dr. med. Mario Roser

Three Content Domains. Unified in CertHub.

MediPureTech

Use Case

Regulations & Key Content

Business Impact

DxTech

Use Case

Regulations & Key Content

Business Impact

SoftiTech

Use Case

Regulations & Key Content

Business Impact

Scaling internationally? We cover your target jurisdictions and regulations.

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

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

Dr. Bernd Krämer

Dr. Michael Gschwandtner

Christoph Sing

Dr. Benedikt Wiechers

Dr. Stefan Leonhardt

Prof. Dr. Oliver Hayden

Stefan Klein

Stephen Prof. Dr. Gilbert

Axel Stepken

Erik Vollebregt

Frequently Asked Questions

Is CertHub Brain GDPR-compliant and where is data stored?

Is CertHub already in use and passed Audits?

Does CertHub provide audit support?

Who is benefiting from using CertHub?

How quickly can I achieve results with CertHub?

How much time and cost can I save with CertHub?

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

What is CertHub Brain?

Which standards & regulatory frameworks does CertHub cover?

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

Can I export my data?

How secure is my data with CertHub?

What happens to my data if I cancel my subscription?

Does CertHub support EUDAMED registration and UDI management?

Do I need to build my own EUDAMED XML solution or use my ERP?

Still have questions?

Your Trusted
Compliance Companion