FDA + MDR Dual Compliance Kit$197
✓FDA vs. MDR Gap Assessment Checklist — every major requirement mapped side-by-side
✓Priority Roadmap: Already FDA Certified? Here's What MDR Adds
✓Top 10 MDR Nonconformances for US Manufacturers Entering EU
✓SOP Template: Supplier Qualification (FDA + MDR Dual-Compliant)
✓SOP Template: CAPA (FDA + MDR Dual-Compliant)
✓"What Auditors Actually Look For" Annotated Guide
MDSAP Virtual Audit Simulation$299
✓MDSAP Audit Overview — all 7 chapters, scoring system, first-time failure patterns
✓60+ Auditor Simulation Questions across all 7 chapters
✓Self-Scoring Gap Assessment — estimated audit grade + priority remediation order
✓Document Checklist by Chapter — every document auditors will request
✓Corrective Action Response Guide — Major/Minor CAR template + worked examples
✓Quick Reference Card — all 7 chapters on one page
IVDR Compliance Kit$197
✓IVDR Classification Tool — determine your IVD class under the new regulation
✓CE Mark Transition Checklist — step-by-step path from IVDD to IVDR
✓Technical Documentation Template — Article 10 compliant structure
✓Article 10 Obligations Checklist — every manufacturer obligation mapped
✓IVDR vs. IVD Directive Gap Analysis — side-by-side comparison
✓Notified Body Selection Guide — criteria, timelines, capacity reality check