Walk into your MDSAP audit knowing exactly what the auditor is going to ask.
The MDSAP Virtual Audit Simulation gives you 60+ realistic auditor questions across all 7 chapters, a self-scoring gap assessment, complete document checklist, and a corrective action guide — built from the experience of manufacturers who’ve been through it.
$299one-time · instant download
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Why MDSAP matters
MDSAP is mandatory for selling Class II–IV devices in Canada, required for Brazil and Australia registration, and increasingly expected by FDA-regulated US customers doing supplier qualification. One audit covers all five markets.
The problem: MDSAP audits are structured differently from ISO 13485 surveillance audits. Manufacturers who prepare for ISO 13485 are often surprised by the depth and country-specific requirements MDSAP adds — particularly in Chapters 2 (complaint handling) and 7 (vigilance). This kit prepares you for what actually happens in the room.
Six documents
01
MDSAP Audit Overview
All 7 chapters explained. Scoring system (Process Grade 1–5). How audits are structured. First-time failure patterns.
02
60+ Auditor Simulation Questions
Realistic questions across all 7 chapters. For each: what the auditor is looking for, common failure modes, what a good answer sounds like.
03
Self-Scoring Gap Assessment
Rate your QMS against each chapter. Output: estimated audit grade, top 5 gaps, priority remediation order.
04
Document Checklist by Chapter
Every document auditors will request. Common deficiency for each. How to prep it before audit day.
05
Corrective Action Response Guide
How to write Major and Minor nonconformance responses. CAR template. Common mistakes auditors reject. Three worked examples.
06
Quick Reference Card
All 7 chapters on one page. Key requirements. Adverse event timing by country. Audit-day mindset.
Who this is for
Quality managers preparing for an initial MDSAP certification audit
Regulatory affairs leads at companies entering the Canadian or Brazilian market
QA teams who have passed ISO 13485 surveillance but haven't done MDSAP yet
Manufacturers who received Major or Minor findings at a previous MDSAP audit and want to prepare better
This is not a general QMS guide. It is a targeted preparation tool for the MDSAP audit specifically, written by someone who has operated in the FDA and ISO 13485 regulated environment and knows where the gaps are.
“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
FAQ
Is this up to date with current MDSAP requirements?
Yes. Content reflects the current MDSAP Audit Approach document and country-specific requirements across all five MDSAP-participating markets (US, Canada, Brazil, Australia, Japan). The scoring model (Process Grades 1–5) and audit chapter structure are current as of 2025.
Do I need MDSAP experience to use this?
No. Written for quality managers who know ISO 13485 but haven't been through MDSAP yet. The audit overview and simulation questions are designed to teach you how MDSAP differs from ISO 13485 surveillance — so you're not learning it from your auditor.
What format are the files?
Six Markdown files, readable in any browser or editor and printable as PDFs. The corrective action template is formatted for immediate use — fill in your device details, root cause analysis, and corrective actions.
What is the refund policy?
Refunds available within 7 days of purchase if the kit doesn't deliver what's described. Email hello@regwatchdaily.com.
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