Our EU MDR training course delivers comprehensive, expert-level knowledge of the latest officially published EU Medical Device Regulation (2017/745). Designed to prepare you for successful regulatory compliance and audits, this course empowers you to confidently navigate the EU MDR framework.
Limited Time Offer: Save $299 — Enroll now for only $500
(Regular price $799)
Completing this EU MDR training course will help you confidently navigate the EU Medical Device Regulation.
Why Choose Our EU MDR Training Course?
This course is uniquely designed by a Certified EU MDR Trainer and former lead auditor for top Notified Bodies including BSI and SGS. Gain insider knowledge on how to prepare for audits and ensure compliance — setting you apart in your career.
Our training covers 53 critical topics across regulatory frameworks, risk management, quality systems, post-market surveillance, and more. Learn at your own pace with one-to-one support and practical tools you can apply immediately.
53 in-depth chapters covering EU legal framework, CE marking, risk management, QMS, and more.
Learn anytime, anywhere with on-demand videos accessible on laptop or mobile app.
Get direct access to expert Q&A to clarify concepts and receive personalized guidance.
Receive a certificate to showcase your skills on your CV and LinkedIn profile.
Understand the regulation’s structure, entry into force, amendments, and current timelines.
Learn the full process from conformity assessment to CE Marking and product release in the EU.
Explore ISO 13485, regulatory compliance strategy, language requirements, and other foundational elements of a compliant QMS.
Learn how to apply risk management principles, classify your device, and develop a compliant Risk Management Plan.
Understand what qualifies as a medical device and how to determine its risk classification under EU MDR.
Learn how to meet Annex I requirements, including labeling, instructions for use, and clinical evaluation.
Get step-by-step guidance on building your technical file and choosing the right route to conformity.
Understand PSURs, PMS plans, vigilance reporting, and how to respond to competent authority actions.
Learn how to assign UDIs, register in EUDAMED, obtain an SRN, and identify your MDN codes.
Isabel Osorio, founder of MDR Consultants, brings 17 years of medical device regulatory experience, including roles as Lead Auditor for BSI & SGS and Certified EU MDR Trainer. Her insider perspective means you get practical, audit-ready insights no other course can offer.
Our training is developed to give you the full picture — not limited by conflict-of-interest restrictions common in other courses.
“Krystal and I really enjoyed your course today! Thank you for your time.” – Jasmin
“This course gave me a clear picture of addressing the complexities of the new regulatory environment under EU MDR.” – Chris
“I appreciate all your help these past few weeks. It’s been a great help preparing us for the audit this week.” – Noemi
Questions? Call us at (786) 306-0227 or email
info@mdrconsultants.com
Quality Assurance & Regulatory Affairs professionals, engineers, supply chain managers, and anyone involved in medical device compliance in the EU.
The course covers EU MDR legal framework, risk management, QMS, CE marking, post-market surveillance, technical documentation, and more.
Yes. Upon completion, you receive a certificate to add to your professional profile.
The course is self-paced; typical completion time is 4-6 weeks depending on your schedule.
Yes. Contact us for custom group training options for 10 or more participants.
Need help implementing EU MDR? Check our consulting services.
