The smartest and most user-friendly solution for MedTech compliance.
We re-invented MDR / IVDR compliance so you can innovate faster and without painful paper-work.
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.
Traditional Medical Devices
Comprehensive QMS and technical documentation for Class I-III medical devices, covering design controls, risk management, clinical evaluation, and regulatory submissions.
ISO 13485 QMS Templates, EU MDR Technical Documentation, Risk Management (ISO 14971), Usability Engineering (IEC 62366)
60% faster regulatory submissions, 40% reduction in regulatory review cycles
In-Vitro Diagnostics
Specialized content for IVD manufacturers including analytical and clinical performance studies, quality control, and IVDR-specific requirements.
IVDR Compliance Templates, Performance Evaluation, Quality Control Procedures, Notified Body Submissions
50% reduction in IVDR transition costs, faster time-to-market for new diagnostics
Software as Medical Device
Complete framework for SaMD development, including software lifecycle processes, cybersecurity, AI/ML validation, and digital health regulations.
IEC 62304 Software Lifecycle, AI Act Compliance, Cybersecurity (ISO 14155), Digital Health Pathways
70% faster SaMD development cycles, future-proof AI Act readiness
CertHub contains the content necessary to be compliant – no extra expenses.
and many more...
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
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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