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IVDR Sherpa
Sherpa identifies the appropriate pathway for IVDR certification of your device and provides a comprehensive overview of applicable requirements
Discover IVDR Sherpa’s Key Features
Device classification
Navigate through dozens of rules and nuanced guidances to understand your device class in minutes
- Systematic classification of your device according to IVDR rules and MDCG guidances
- Detailed rationale for each rule including any inferred data
- Stress test your classificaiton versus existing approved devices in EUDAMED
Conformity route
Get a detailed overview of primary and applicable alternative conformity routes for your device
- Detailed overview of primary and applicable alternative conformity routes
- Explanation of applicable processes for conformity (Notified Body involvement, special consultantions, scrutiny procedure, audit cycle, technical, clinical and post-market documentation obligations)
QMS & GSPR requirements
Map out the deliverables for your QMS and General Safety & Performance Requirements
- Detailed list of applicable Quality Management System foundation requirements with deliverables and rationale each.
- Detail of applicable General Safety & Performance Requirements clauses
AI Act
Seamlessly integrate AI Act requirements
- Identify high risk classification according to AI act
- Map out applicable AI act requirements on GSPR deliverables
Guidances & Standards
Identify applicable MDCG guidances and harmonized standards
- Get an overview of MDCG guidances applicable to your product
- Detailed summary of applicable recommendations for each guidance
- Get an overview of harmonized standards applicable to your product
- Detailed rationale witht the scope of the standard and rationale why it applies
IVDR certification requires expert interpretation of complex rules. Now available at the press of a button.
