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Pass Your Next EU MDR & ISO 13485 Audit with a Former Notified Body Auditor in Your Corner
MedComplaiSolutions helps SaMD and AI-driven medical device companies across the EU close compliance gaps, prepare for audits, and build QMS / AI management systems that scale - in English or French.
20+ years in Quality & SaMD | Former Notified Body Lead Auditor |
Bilingual EN/FR | Based in Spain, serving the EU
Not ready to talk yet?
You're Building Products that Save Lives.
Don't Let an Audit Stop You.
Whether you're preparing for your first MDR submission, recovering from a tough audit, or scaling your QMS for an AI-powered medical device, the regulatory bar in Europe is high, and the cost of getting it wrong is higher.
I've spent 20+ years inside the medical device industry specializing in SaMD and Quality, including years auditing companies for a global Notified Body. I now bring that insider's lens to SaMDs and medical device companies across the EU so you walk confidently into your next audit knowing exactly what the auditor is looking for.
No jargon. No bloated retainers. Just the right work, done right, the first time.
How I Can Help
Four focused services. Each designed to move you from compliance anxiety to audit-ready confidence.
For:
SaMD & medical device companies preparing for first certification or restructuring an underperforming QMS.
ISO 13485 QMS
Build & Audit Readiness
What you get:
-
A QMS designed to pass audits, built by someone who used to run them
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Full ISO 13485 GAP Analysis with a prioritized risk-based remediation roadmap
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Practical CAPA, Complaints, Supplier Management & Training procedures your team will actually follow
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Audit-day readiness coaching from a former Lead Auditor who knows the reviewer's mindset
Outcome:
A lean, defensible QMS integrated into your modern software workflow that does not slow down your sprint cycles.
For:
Companies with an EU Notified Body audit on the horizon or those needing to rapidly resolve post-audit findings.
Mock Audits, Internal Audits & Critical Vendor Evaluations
What you get:
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A rigorous mock audit that mirrors what your Notified Body will actually do
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Findings ranked by audit risk, not theoretical importance
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Clear, actionable CAPA guidance to close gaps fast
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Critical software vendor audits that strengthen your supply chain before an auditor questions them
Outcome:
No surprises on audit day. Existing findings closed effectively before they escalate into major nonconformities.
For:
SaMD & AI-enabled medical device companies preparing for the EU AI Act and ISO 42001.
ISO 42001 AI Management System Implementation
What you get:
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Practical AIMS framework integrated with your existing ISO 13485 QMS
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AI risk management aligned with EU AI Act requirements for high-risk medical AI
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Gap analysis of your current AI governance against ISO 42001
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Audit ready templates for AI lifecycle, data governance, and post-market algorithmic monitoring
Outcome:
Compliant medical AI that satisfies European regulators while keeping your development roadmap unblocked.
For:
Companies preparing for technical documentation submission for MDR certification, or building post-market surveillance from scratch.
EU MDR Submission & Post-Market Compliance
What you get:
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Software technical documentation review (including IEC 62304 artifacts) through the eyes of a former Notified Body Auditor
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Post-Market Surveillance (PMS) plans that satisfy MDR Article 83-86
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Management Review preparation, software metrics structuring, and reporting guidance
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Submission readiness sign-off before your file goes to your Notified Body
Outcome:
A robust, professional submission that lands the first time, not after three rounds of Notified Body questions.
About the Founder
My name is Jacques Samy.
For the last 20+ years I have worked inside medical device Quality and SaMD - first building compliance systems from the inside, then spending years as a Lead Auditor for a global Notified Body, where I personally audited hundreds of SaMD and medical device companies.
I founded MedComplaiSolutions because I kept seeing the same pattern from the other side of the audit table: strong products failing certification not because they were unsafe, but because their compliance systems weren't built with audit reality in mind.
Today, I bring the precise auditor's lens directly to SaMD and AI-driven medical application manufacturers across the EU. I help you navigate the overlapping complexities of EU MDR, IEC 62304, and the EU AI Act so your team can walk into your next audit knowing exactly what the auditor is looking for and why.
Why Work With Me
Former Notified Body Auditor
I know the questions, the red flags, and the documentation auditors actually open.
20+ Years in
SaMD & QMS
No on-the-job learning at your expense.
Bilingual: EN/FR
Clear communication across the European Union.
EU-Based,
EU-Focused
Local timezone, context, and regulatory reality.
Solo & Senior
You work directly with me, not a junior consultant with a senior pricetag.
Trusted Expertise
ISO 13485 | EU MDR | ISO 42001 | ISO 14971
IEC 62304 | ISO 27001 | FDA 21 CFR 820
Let's Talk About Your Compliance Project
Tell me a little about where you are in your compliance journey. I'll respond within one business day with next steps, or to schedule your free 30-minute call. Disponible en français sur demande.
Not Ready to Talk? Start Here.
Download the Free SaMD EU MDR Show Stoppers Checklist.
A 15-point self-assessment built from real Notified Body audit experience.
In just 10 minutes, discover whether your SaMD or AI-driven medical device has any of the regulatory show stoppers that commonly delay or derail EU MDR certification.
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