Everything. One Price. Save $688.

The Complete Compliance Suite

Five toolkits covering the full regulatory stack: dual-market compliance, MDSAP audit readiness, QMSR transition, IVDR, and FDA cybersecurity. Everything a medical device manufacturer needs for the next 24 months of regulatory enforcement.

Dual Compliance Kit$197MDSAP Audit Sim$299QMSR Transition Toolkit$297IVDR Compliance Kit$197FDA Cybersecurity Toolkit$247Total separately$1,237Bundle price$549

Instant download. All 34 documents across 5 toolkits.

34 documents. 5 toolkits. All of it.

Each toolkit ships independently — the bundle gives you all five at once.

Dual Compliance Kit

$197 value

6 documents mapping your FDA QMS to EU MDR requirements. Gap assessment, priority roadmap, top 10 MDR nonconformances, and 2 dual-compliant SOP templates.

  • FDA vs. MDR Gap Assessment Checklist
  • Priority Roadmap: What MDR Adds to Your FDA Baseline
  • Top 10 MDR Nonconformances for US Manufacturers
  • SOP Template: Supplier Qualification (FDA + MDR)
  • SOP Template: CAPA (FDA + MDR)
  • "What Auditors Actually Look For" Annotated Guide

MDSAP Virtual Audit Simulation

$299 value

6 documents simulating a full MDSAP multi-country audit. Graded scenario pack, clause-by-clause prep guide, evidence matrix, CAPA response templates, and pre-audit checklist.

  • MDSAP Audit Overview — all 7 chapters, scoring system
  • 60+ Auditor Simulation Questions across all 7 chapters
  • Self-Scoring Gap Assessment
  • Document Checklist by Chapter
  • Corrective Action Response Guide
  • Quick Reference Card — all 7 chapters

QMSR Transition Toolkit

$297 value

6 documents covering the full QMSR transition from 21 CFR Part 820. Gap analysis checklist, SOP revision guide, risk management integration, supplier controls, PMS plan, and inspector prep.

  • QMSR Gap Analysis Checklist (80+ checkpoints)
  • SOP Revision Guide — specific language changes required
  • Risk Management Integration Guide (ISO 14971:2019)
  • Supplier Controls Update Template + Quality Agreement
  • Post-Market Surveillance Alignment Guide
  • FDA Inspector Prep Checklist

IVDR Compliance Kit

$197 value

6 documents covering the EU In Vitro Diagnostic Regulation. Classification tool, CE mark transition checklist, Article 10 obligations, technical documentation template, and notified body selection guide.

  • IVDR Classification Tool — determine your IVD class
  • CE Mark Transition Checklist — IVDD to IVDR step-by-step
  • Technical Documentation Template — Article 10 compliant
  • Article 10 Obligations Checklist — every manufacturer obligation
  • IVDR vs. IVD Directive Gap Analysis
  • Notified Body Selection Guide

FDA Cybersecurity Toolkit for Medical Devices

$247 value

10 documents covering Section 524B compliance and FDA 2023 cybersecurity guidance. Threat model, risk assessment, SBOM, security architecture, vulnerability management, and post-market monitoring.

  • Threat Model Template (STRIDE-based, FDA-aligned)
  • Cybersecurity Risk Assessment Worksheet
  • Software Bill of Materials (SBOM) Template
  • Security Architecture Document Template
  • Vulnerability Management Plan
  • Pre-Submission Cybersecurity Checklist
  • Patch Management Policy Template
  • Vulnerability Disclosure Procedure
  • Cryptographic Bill of Materials (CBOM) Template
  • Post-Market Cybersecurity Monitoring Plan

Why bundle

🎯

One purchase. Five inspection scenarios covered.

FDA QMSR gap inspection, MDSAP multi-country audit, EU MDR conformity assessment, IVDR compliance, and FDA cybersecurity. All five toolkits built around what auditors actually look for.

📋

34 working documents, not a course.

No video modules. No quizzes. Practitioner-level documents your QA team can use this week.

💰

$688 cheaper than buying separately.

Five toolkits bought individually: $1,237. The bundle: $549. Same documents, one purchase.

The regulatory stack is connected.

QMSR defines your QMS foundation. MDSAP audits that QMS across five jurisdictions. EU MDR applies that QMS to a second regulatory framework. IVDR extends it to in vitro diagnostics. These aren't separate problems — they're four angles on the same compliance posture.

$20K–$80K
Consultancy (all 5 areas)
40–80 hrs
483 CAPA cycle
$549
This bundle

Stripe checkout. Instant download after payment.

Who this is for

  • QA Director or VP of Regulatory at a Class II/III or IVD company planning for MDSAP certification within 24 months
  • Manufacturer who is ISO 13485 certified, under FDA jurisdiction, and looking at EU MDR or IVDR market entry
  • Company with a QMSR transition still in progress + MDSAP due date approaching
  • IVD manufacturer preparing for the IVDR transition deadline
  • Regulatory consultant advising multiple small device or IVD manufacturers

Frequently asked

Can I also buy these individually?

Yes — each toolkit is available separately. If you only need one, start there. If you need all four, the bundle saves $441.

Is this for a US-only manufacturer?

The Dual Compliance Kit and IVDR Kit specifically address EU market entry. The QMSR Toolkit and MDSAP Audit Sim are relevant for any manufacturer under FDA jurisdiction or in the MDSAP program.

What format are the documents?

Markdown — formatted for immediate use with your document control system. Clean, structured, ready to adapt.

Five toolkits. One price. Everything you need for the next inspection.

FDA QMSR inspection, MDSAP audit, EU MDR conformity assessment, IVDR compliance, FDA cybersecurity compliance. All covered.

Or buy individually: DCK $197 · MDSAP $299 · QMSR $297 · IVDR $197 · Cybersecurity $247