Conformity Assessment & Audit Defense:
Right-First-Time Submissions.
Stop fearing the Notified Body review. Medea aligns your clinical output with the internal review workflows of NBs to ensure your Technical Documentation (TD) is complete, compliant, and ready for scrutiny. Reduce the risk of "clock-stops" and immediate rejections.
Designed for the Notified Body Assessment Process
Notified Bodies follow a standardized, multi-stage process for certification. Medea is built to provide the exact data structure and scientific rigor required at each critical milestone.
Step 1-2: Automated Completeness Checks
Medea acts as your internal auditor, ensuring all Annex II and III requirements are addressed before you submit your application, passing the NB "Completeness Check" on the first attempt.
Step 3-4: Technical Documentation (TD) Assessment
Generate machine-read, structured evidence that mirrors the level of detail NB reviewers demand during technical assessments.
Step 5-7: Expert Consultation & Final Decision
For Class III and IIb devices, Medea provides the high-level Clinical Evaluation Consultation Procedure (CECP) rigor required for final certification decisions.
Closing Regulatory Gaps in Technical Files
Software/Cybersecurity Readiness
Centralize documentation for cybersecurity and software performance, critical areas of modern NB scrutiny.
Annex I GSPR Mapping
Link clinical evidence to specific GSPRs with AI suggestions your team validates.
AI-Assisted Traceability Matrix
Maintain a complete digital audit trail from initial literature screening to final clinical conclusions.
Defensible Equivalence Claims
Accelerate the rigorous comparative analysis needed to justify equivalence under the stricter MDR Annex XIV standards.
Preventing Submission Quality Issues
Current data shows that 75% of submissions are only 50% complete, leading to years of certification delay. Medea solves this "Submission Quality Crisis"
1
Prevent Failed Audits
Address common pitfalls like inconsistent intended purposes or gaps in third-party supplier documentation.
2
Protect Market Revenue
Every month lost in the conformity assessment loop costs between €500K–€2M in lost revenue. Medea ensures your GTM timelines remain predictable.
Frequently asked questions
Here are some common questions about Conformity Assessment.
Medea performs a pre-submission sweep of your Technical Documentation to ensure all required elements—including clinical evidence and GSPR mapping—are present and searchable, preventing administrative rejection.
Audit Defense refers to Medea's ability to provide an immediate, digital audit trail for every claim in your CER. If an auditor questions an evidence point, you can show the exact source and appraisal logic in seconds.
Yes. Medea specifically manages the complex documentation required for legacy device transition periods extending to 2027/2029, ensuring continuous market availability.
Build an Audit-Proof Submission TodayBody
Don't leave your conformity assessment to chance. Deploy the Swiss-made system designed to ensure your regulatory success.