Two years in development. 48 technical chapters.
A systemic deep-dive designed by a former Lead Auditor at BSI and SGS, bridging EU MDR regulatory text and operational implementation, and giving you the auditor-level insights needed to build a fully audit-ready QMS.
Notified Bodies must remain impartial and cannot provide direct implementation guidance. This program delivers the practical strategies and frameworks needed to translate the regulation into an audit-ready Quality Management System.
A Curriculum Built on the Highest Level of Professional Qualification.
Demonstrable competence is your strongest safeguard against systemic non-conformity. MDR Consultants provides an implementation framework developed from direct Notified Body auditor qualification experience, reflecting the technical evaluation standards used to assess and recertify Lead Auditors at BSI and SGS.
Our founder, Isabel Osorio, held the rare authority to qualify and recertify internal Notified Body auditors, establishing the global benchmark for EU MDR 2017/745 competence.
We teach you the specific QMS implementation solutions that Notified Body auditors are legally prohibited from sharing due to conflict-of-interest laws.
Master the technical core of Regulation (EU) 2017/745 through auditor-level implementation logic.
Master the Conformity Assessment logic required to verify and defend compliance for EU market release.
Identify which Safety & Performance requirements apply to your device and learn the documentation logic auditors expect to see.
Architect the integrated lifecycle. Align Clinical Investigations, CERs, and PSURs to ensure a seamless, audit-ready data loop.
Go beyond ISO 13485. Learn the Article 10 systemic updates needed to successfully transition your entire Quality System.
Auditor-Level Certificate Issued by MDR Consultants
Gain the technical fluency to architect a Quality Management System that survives Notified Body scrutiny. This curriculum—updated to include the January 1, 2026 legal framework —provides the implementation logic required to ensure your QMS and technical processes are fully conformant with Regulation (EU) 2017/745 and all subsequent amendments.
The definitive EU MDR 2017/745 curriculum for QMS professionals.
We move beyond theoretical reading. Every module is architected to translate the EU MDR 2017/745 into a functional QMS strategy, ensuring you have the competence to defend your system during an audit.
Plus, you will gain access to technical insights and implementation frameworks designed to be applied to your organization immediately.
SECURE YOUR ENROLLMENTMoving from "Standard Quality" to "MDR Audit-Ready" requires specific systemic transitions. We provide the technical logic to navigate these four key pillars.
I founded MDR Consultants after a 17-year career where I reached the highest level of regulatory authority: I held authorization to qualify and recertify internal Notified Body Lead Auditors operating under EU MDR 2017/745.
I didn't just conduct audits for the world’s most rigorous Notified Bodies; I evaluated the experts who perform them. I spent two years architecting this 48-chapter curriculum and have continuously updated it to reflect every regulatory amendment to provide the one thing "official" training cannot: Unrestricted Implementation Logic.
The Industry's 'Missing Link':
Official courses from Notified Bodies are legally restricted by conflict-of-interest laws. They can point to a failure in your QMS, but they are forbidden from showing you how to fix it. They can only reiterate the text of the regulation.
Because I am now independent, I bridge that gap. I combine my experience as a Biomedical Engineer and Certified Auditor Trainer to give you the complete implementation roadmap. You will learn exactly how to architect a Quality Management System that doesn't just "read" as compliant, but survives the most aggressive 2026 audits.
ENROLL NOW
Specifically designed for the Person Responsible for Regulatory Compliance (PRRC) and Quality Managers who must demonstrate “requisite expertise” under Article 15.
Gain the technical fluency to ensure compliance from phase one, preventing costly redesigns by executing GSPRs and Classification logic.
Essential for those managing UDI, SRN, and Eudamed reporting to ensure the physical movements of goods meet the 2026 digital traceability standards.
★★★★★
Krystal and I really enjoyed the course! The level of expertise shared is exactly what we were looking for to ensure our internal systems are compliant.
★★★★★
I chose this course because it was designed by someone with hands-on experience implementing EU MDR 2017/745 and the unique perspective of an auditor for one of the most challenging Notified Bodies on the market.
★★★★★
This provided a clear picture of how to address the complexities of the new regulatory environment under EU MDR. We truly appreciate the depth of information provided.
★★★★★
I appreciate all your help these past few weeks. This training has been a massive help in preparing us for our audit this week. It gave us the clarity we needed to move forward with confidence.
Want more details? Want to make sure this course is the right fit for you?
Contact a course advisor:
📞 (786) 306-0227
✉️ info@mdrconsultants.com
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