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MDR Sherpa

Sherpa identifies the appropriate pathway for MDR certification of your device and provides a comprehensive overview of applicable requirements

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Discover MDR 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 MDR 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

MDR certification requires expert interpretation of complex rules. Now available at the press of a button.

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