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.
Hear from our customers!
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.
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.
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.
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.
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.
CertHub has customers ranging from software to hardware products with risk classes I, IIa, IIb and III with focus on SMEs
CEO and Co-Founder Kumovis (3D Systems)
Head of Translatum & TUM Chair of Biomedical Electronics Academic Director MedTech, Venture Labs Healthcare
Regulatory Affairs Manager HP Medizintechnik GmbH & MD at HP Med Consulting GmbH
Founder & CEO Ocumeda
Managing Director & Founder Evoleen
Head of QM & RA FRIZ Biochem GmbH
Executive Director Advanced Technology | Global Research & Development bei Karl Storz SE & Co. KG
Freelance Auditor for multiple Notified Bodies, Medical Device Expert
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.
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.
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.
Depending on the complexity of your project, CertHub can help you create compliant documentation ranging from few days to few months instead of years.
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
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.
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.
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.
Yes, you can export your data anytime with a single click, ensuring flexibility and control over your documentation
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.
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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