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Agreement – Distributor Template Agreement (MDR & IVDR)
Agreement – EU Authorized Representative Template Agreement (MDR & IVDR)
Agreement – Importer Template Agreement (MDR & IVDR)
Agreement – Supplier Template Agreement (MDR & IVDR)
Agreement PRRC – Manufacturer (EU MDR & IVDR)
BUNDLE Premium Pack – EU MDR Technical File
Bundle Tech File (Template and Checklist) + GSPR + DoC
Clinical Evaluation MDR Pack (CEP + CER)
Coaching – 5h package
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Drug-Device Technical Doc – Article 117 EU MDR
e-Training – Audit Readiness
eTraining – Vigilance Reporting – EU Regulation
FDA Letter to File Template
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