Master the MDR Pathway with Audit-Proof Clinical Evidence.
Stop risking market blocks for your Class IIb and III devices. HubMed provides the only AI-driven ecosystem designed to ensure your Technical Files are always defensible and gap-free. Navigate the 7-Step Conformity Assessment with precision and maintain continuous market access..
Solving the Submission Quality Crisis
In the current regulatory landscape, 75% of manufacturer submissions are reported as less than 50% complete by Notified Bodies. These documentation gaps lead to "clock-stops" and immediate rejections. HubMed eliminates these bottlenecks
Preventing Market Blocks
Every month of certification delay represents €500K–€2M in lost revenue. We ensure your submission is "Right-First-Time".
Defensible Clinical Evidence
Move beyond manual spreadsheets. Our platform creates a digital "Evidence Vault" that justifies every claim under MDR Annex XIV.
Automated Audit Defense
Be prepared for the unexpected. Provide Notified Bodies with 100% traceable data continuity from preclinical discovery to post-market surveillance.
Precision Tool for Regulatory Excellence
Medea | Clinical Evaluation & SOTA Automation
Automated CER Done Right:
Use the PICO framework to automate Systematic Literature Reviews (SLR) and State of the Art (SOTA) analysis.
GSPR Mapping Automation:
Automatically link clinical evidence to General Safety and Performance Requirements (GSPRs) for Annex I compliance.
Resolving Complexity. Ensuring Compliance.
HubMed acts as your digital regulatory partner, ensuring that human error—inevitable when managing 200+ documents for a single device—does not compromise your market access.
Swiss-Made Reliability: Engineered to the highest standards of precision to safeguard your sensitive clinical data.
IP Security: A secure environment for your intellectual property, ensuring full GDPR compliance and Swiss data privacy standards.
Frequently asked questions
Here are some common questions about PICO & Clinical Compliance.
The PICO framework ensures that literature searches are structured, objective, and reproducible. This methodology is preferred by Notified Bodies because it eliminates selection bias and ensures a gap-free Clinical Evaluation Report (CER).
Yes. HubMed specifically manages the complex documentation required to utilize extended transition periods (up to 2027/2029), ensuring your legacy devices remain on the market while transitioning to MDR/IVDR.
By automating the Completeness Check and aligning documentation with the internal review workflows of Notified Bodies, Medea delivers submissions that are far less likely to be flagged for missing or poor-quality data.
Secure Your Product’s Lifecycle Today
Don't let regulatory complexity block your innovation. Join the manufacturers ensuring compliance with Swiss AI precision.