11 Toolkits · 66 Documents · Complete Coverage

Complete FDA + MDR Compliance Suite

Every toolkit your QA team needs — from QMSR and ISO 14971 to MDSAP audits, EU MDR, IVDR, SaMD, Design Controls, CAPA, and Post-Market Surveillance.

$997
$2,717 if purchased individually
You save $1,720 (63% off)

Stripe checkout · Instant delivery · 66 documents across 11 toolkits

Watch: Why 500+ device companies use the Complete Compliance Suite

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What's inside

QMSR Transition Toolkit$297
ISO 14971 Risk Management Toolkit$247
Dual Compliance Kit — FDA + MDR$197
MDSAP Virtual Audit Simulation$299
EU IVDR Compliance Starter Kit$197
Device Cybersecurity Toolkit$247
Post-Market Surveillance Toolkit$247
SaMD Regulatory Toolkit$247
Design Controls Toolkit$247
Supplier Controls Toolkit$247
CAPA Toolkit$247

All 11 toolkits included. $2,717 standalone → $997 as a suite.

These toolkits form a complete compliance infrastructure.

QMSR defines your QMS foundation. ISO 14971 defines the risk management system. Design Controls govern your DHF. Supplier Controls protect your supply chain. CAPA closes the loop on nonconformances. Post-Market Surveillance keeps you compliant after launch. EU MDR and MDSAP extend coverage globally.

These aren't 11 separate products. They're 11 layers of the same compliance stack — the one FDA inspectors and notified bodies expect to see running together.

66 documents. 11 toolkits. Complete coverage.

Each toolkit ships independently — the suite gives you all 11 at once.

QMSR Transition Toolkit

$297

Close your 21 CFR Part 820 gaps before your next FDA inspection. The grace period ended February 2, 2026.

  • 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

ISO 14971 Risk Management Toolkit

$247

Build the complete risk management file FDA QMSR and MDR notified bodies expect. Full lifecycle coverage.

  • Risk Management Plan Template (ISO 14971:2019 §4)
  • Risk Analysis Worksheet (FMEA + use-related + FTA)
  • Risk Evaluation and Control Guide (§7-8)
  • Risk Management Report Template (§10)
  • Post-Market Surveillance Integration Guide
  • FDA + MDR Audit Alignment Checklist

Dual Compliance Kit — FDA + MDR

$197

Map your FDA QMS to EU MDR requirements. Gap assessment, roadmap, top nonconformances, and 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

Simulate a full MDSAP multi-country audit. 60+ auditor questions, document checklist, CAPA response templates.

  • 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

EU IVDR Compliance Starter Kit

$197

Bridge your FDA IVD file to EU IVDR compliance. Six templates covering performance evaluation, technical documentation, risk management, PMS, and notified body prep.

  • Performance Evaluation Plan Template (IVDR Annex XIII)
  • Technical Documentation Checklist (Annex II/III — Class A/B/C/D)
  • Risk Management Plan Template (ISO 14971:2019 for IVDs)
  • Post-Market Surveillance Plan (IVDR Article 79 + PMPF)
  • Notified Body Preparation Guide (Class C/D pre-submission)
  • FDA vs. IVDR Gap Analysis (21 CFR Part 809 side-by-side)

Device Cybersecurity Toolkit

$247

Meet FDA cybersecurity expectations for 510(k) submissions and post-market management. Built to the 2023 FDA Cybersecurity Guidance.

  • Cybersecurity Risk Assessment Template (STRIDE methodology)
  • 510(k) Cybersecurity Documentation Checklist
  • SBOM (Software Bill of Materials) Template
  • Cybersecurity Management Plan Template
  • Incident Response Plan Template
  • FDA Cybersecurity Premarket Guidance Alignment Checklist

Post-Market Surveillance Toolkit

$247

Build a complete post-market surveillance system that satisfies FDA QMSR §820.70 and EU MDR Article 83-86 requirements.

  • PMS Plan Template (FDA QMSR + EU MDR Article 84)
  • PMCF Protocol Template (MDR Annex XIV Part B)
  • Periodic Safety Update Report (PSUR) Template
  • Complaint Handling SOP (21 CFR 820.198 + MDR)
  • FSCA Decision Tree and Notification Template
  • PMS Summary Report Template

SaMD Regulatory Toolkit

$247

Navigate SaMD classification, IEC 62304 software lifecycle, and FDA PCCP requirements. Built for medical AI and software developers.

  • SaMD Classification Worksheet (FDA + IEC 62304)
  • IEC 62304 Software Lifecycle Planning Template
  • SOUP (Software of Unknown Provenance) Management Plan
  • FDA PCCP (Predetermined Change Control Plan) Template
  • Cybersecurity SaMD Checklist (FDA 2023 Guidance)
  • 510(k) SaMD Documentation Checklist

Design Controls Toolkit

$247

Build a defensible Design History File from day one. Covers FDA QMSR 21 CFR 820.30 and ISO 13485 §7.3 requirements.

  • Design Control Plan Template (820.30 compliant)
  • Design Input Requirements Template
  • Verification & Validation (V&V) Plan Template
  • Design History File (DHF) Index Template
  • Design Review Meeting Template
  • Design Transfer SOP

Supplier Controls Toolkit

$247

Build an audit-ready supplier qualification program. Covers FDA QMSR 21 CFR 820.50 and ISO 13485 §7.4 requirements.

  • Supplier Qualification Program Template
  • Supplier Audit Checklist (FDA + ISO 13485)
  • Quality Agreement Template
  • Approved Supplier List (ASL) Template
  • Supplier Performance Review Template
  • Incoming Inspection SOP

CAPA Toolkit

$247

Build a CAPA system that satisfies FDA inspectors and ISO 13485 auditors. Includes root cause analysis, effectiveness verification, and trend tracking.

  • CAPA Procedure (21 CFR 820.100 + ISO 13485 §8.5.2)
  • Root Cause Analysis Worksheet (5-Why + Ishikawa)
  • CAPA Form + Log Template
  • Effectiveness Check Protocol
  • CAPA Trend Dashboard Template
  • FDA Inspection CAPA Preparation Guide

Why bundle

📦

66 documents

Every template, checklist, SOP, and guide across all 11 toolkits. Ready to customize.

🌍

Global coverage

FDA QMSR, EU MDR, IVDR, MDSAP, ISO 13485, IEC 62304, ISO 14971. One purchase.

⚡

Instant delivery

Stripe checkout. Files delivered immediately to your inbox. No waiting.

💰

Save $1,720

Buy all 11 individually: $2,717. This suite: $997. That's 63% off.

The full compliance stack. One price.

$30K–$100K
Consultancy (all 11 areas)
Months + rework
Cost of a compliance gap
$997
This suite

Stripe checkout. Instant download. 66 documents.

Who this is for

  • QA Director or RA Manager at a Class II/III device company managing FDA + EU MDR compliance simultaneously
  • ISO 13485-certified manufacturer under FDA jurisdiction maintaining or preparing for MDSAP participation
  • SaMD / medical AI company navigating IEC 62304, FDA cybersecurity guidance, and PCCP requirements
  • Company building out Design Controls, CAPA, and Supplier Controls for the first time or overhauling existing systems

Also available individually: Each toolkit can be purchased separately. Browse all 14 products →

11 toolkits. One purchase. The complete compliance stack.

FDA QMSR · ISO 14971 · MDSAP · EU MDR · IVDR · Cybersecurity · SaMD · Design Controls · CAPA · Supplier Controls · Post-Market Surveillance

Or browse individually at regwatchdaily.com/tools