FDA + EU MDR · 6 Documents

Ship compliant medical devices in the US and EU — without hiring a regulatory consultant

The FDA + MDR Dual Compliance Starter Kit gives you the exact templates, checklists, and SOPs used by contract manufacturers navigating both markets.

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Who this is for

Quality managers and founders at small-to-mid US medical device manufacturers (Class I/II) who have FDA clearance and are now facing EU MDR requirements to sell into European markets. You own audit prep, you write or manage SOPs, and you don’t have a €50k/year EU regulatory consultant on retainer. You know the FDA framework. You don’t know what MDR adds, where it diverges, and what EU notified bodies actually scrutinize. This kit closes that gap.

Six deliverables

01
FDA vs. MDR Gap Assessment Checklist
4-page PDF
Every major requirement category mapped side-by-side: FDA 21 CFR Part 820 vs. EU MDR 2017/745. Color-coded by gap severity. Covers design controls, risk management, CAPA, supplier qualification, labeling, PMS, UDI, and technical documentation. Use it as an audit prep checklist — checkboxes included.
02
Priority Roadmap: Already FDA Certified? Here's What MDR Adds
Visual roadmap + 3-page guide
A sequenced action plan for manufacturers who start from an FDA baseline. The 12 things notified bodies scrutinize first, in the order you should tackle them. Estimated effort per item. Flags what your US QA team can handle vs. what needs EU support.
03
Top 10 MDR Nonconformances for US Manufacturers Entering EU
6-page PDF
The 10 most common audit findings against US manufacturers in their first EU MDR review. Each one includes: what it is, why US manufacturers get it wrong (the FDA mindset trap), and how to close it before the audit.
04
SOP Template: Supplier Qualification (FDA + MDR Dual-Compliant)
.docx + PDF, ~8 pages
A fill-in-the-blank SOP written to satisfy both 21 CFR Part 820.50 and MDR Annex IX/XI supplier control requirements simultaneously. Supplier risk matrix, qualification checklist, annual re-evaluation process, critical supplier escalation path, audit trail documentation.
05
SOP Template: CAPA (FDA + MDR Dual-Compliant)
.docx + PDF, ~10 pages
A CAPA SOP covering 21 CFR Part 820.100 and MDR Article 83/88 post-market obligations simultaneously. Root cause analysis framework, effectiveness check criteria, FSCA trigger logic for MDR, and EUDAMED serious incident reporting flow. One SOP satisfies both regulators.
06
"What Auditors Actually Look For" Annotated Guide
12-page annotated PDF
Real MDR audit findings annotated with commentary: what the auditor was looking for, what the manufacturer provided, and what the gap was. FDA 483 observations vs. MDR nonconformances — the difference in severity framing, documentation standards, and response expectations.

From the teams who built this

“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

Common questions

I can find this on the EU MDR website for free.
You can find the regulation. You can't find a plain-language explanation of exactly where your FDA QMS falls short of MDR, in prioritized order, with templates that close the gap. That's what this kit is.
Why $197 and not free or $97?
A single hour with an EU regulatory consultant costs $300–$500. This kit delivers six documents built from the same knowledge base. $197 is priced so a quality manager can expense it without a procurement approval — but high enough that you'll actually use it.
Does this replace a notified body or regulatory consultant?
No. It gets you to audit readiness, not expert status. Use this to close the obvious gaps before you engage a consultant — so you're paying them for judgment calls, not orientation.
Is this up to date with current regulations?
Yes. Content reflects FDA 21 CFR Part 820 and EU MDR 2017/745 as currently enforced. The MDR application date was May 2021 for most devices; guidance referenced is current as of 2025.
What format are the files?
Six files total. Checklists and guides are in Markdown (readable in any browser or editor). SOP templates (Documents 04 and 05) include both .docx and PDF versions. You can edit the SOPs in Word or Google Docs.
Do I need regulatory experience to use this?
No. Written for quality managers who know the FDA framework but are new to MDR. Jargon is explained in context. The gap assessment checklist walks you through the comparison requirement by requirement.
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. No questions asked.

Ship compliant in both markets.
Six deliverables. $197.

Gap assessment · Priority roadmap · Top 10 nonconformances · Supplier qualification SOP · CAPA SOP · Auditor annotation guide

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