What is the Real Cost of Your Manual CER Maintenance?
Stop guessing your regulatory overhead. Use our Swiss-engineered calculator to uncover the hidden costs of manual clinical evaluation and see how much you could save with Medea™, the HubMed™ Workflow Engine.
Why Are RA/QA Teams Automating Their EU MDR CER Maintenance?
Stop the "Reading Fatigue"
Automate the systematic screening of thousands of articles. Let your experts focus on analysis, not searching.
Standardized PICO Framework
Built-in scientific methodology ensures your clinical evidence appraisal meets the strictest Notified Body requirements (MDR/IVDR) by design.
Ensure First-Time-Right Submissions
Reduce "Rounds of Questions" (RsQs) from Notified Bodies by using a standardized, PICO-driven evidence appraisal.
Precision Intelligence, Swiss-Secured
Your clinical data is a competitive asset. We protect it in our high-security Swiss Vault.
The Cost of Non-Compliance: What is the Real Price of an MDR Documentation Gap?
In the rigorous landscape of MDR and IVDR, "good enough" documentation is a liability. A single rejected Clinical Evaluation Report (CER) or a Major Non-Conformity (NC) can trigger a chain reaction of financial and operational setbacks.
The Hidden Penalties of Manual Processes
Market Access Delays:
Every month your device is "In-Review" due to preventable Rounds of Questions (RsQs) can cost between €50.000 and €200.000 in lost revenue.
Notified Body Bottlenecks:
With current NB capacity at its limit, a technical file rejection can push your certification back by 12 to 18 months.
Resource Drain:
Rectifying a single Major NC often requires 300+ man-hours of emergency corrective action, pulling your senior R&D team away from innovation.
Reputational Risk:
Frequent data gaps signal systemic weakness to regulators, leading to increased audit frequency and higher scrutiny on future submissions.
Ready to Modernize Your Regulatory Model?
Don’t let manual documentation delay your market access. Discover how Medea™, the HubMed™ Workflow Engine, protects your product lifecycle and secures permanent compliance.