Master Medical Device Regulatory Training

Master medical device regulatory training with expert-led courses for EU MDR, FDA QMSR, and ISO 13485. Developed by former Notified Body auditors, our courses bridge the gap between regulatory theory and real-world implementation.

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Certification from Real-World Experts

Enhance your professional profile with credentials valued by employers and auditors.

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Audit-Proven Training Methods

Learn compliance approaches tested in real notified body and FDA audits.

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Flexible Learning for Busy Professionals

Self-paced online courses or live sessions tailored to your schedule.

Featured Medical Device Regulatory Training Courses

EU MDR 101 – Online Course

Foundations of EU Medical Device Regulation

This EU MDR compliance training delivers a comprehensive understanding of Regulation (EU) 2017/745, taught by former Notified Body auditors.

  • Device classification & conformity assessment
  • Technical documentation requirements
  • Post-market surveillance strategies

Course Details

EU MDR 101 training course
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FDA QMSR regulation visual
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QMSR Transition – FDA Course

FDA’s New Quality System Regulation

Get your team aligned with the new FDA QMSR training and its transition to ISO 13485 compliance.

  • Clause-by-clause comparison tool
  • Gap assessment methodology
  • Inspection readiness checklist

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Trusted by Medical Device Professionals

★★★★★

“The EU MDR course gave me the confidence to lead our transition project. The practical examples were exactly what our team needed.”

– Quality Director, Orthopedic Implant Manufacturer

★★★★★

“Finally a training that explains not just what the regulations say, but how to implement them efficiently.”

– RA Specialist, Diagnostic Equipment Company

★★★★★

“The QMSR preview session saved us months of guesswork. Looking forward to the full course launch!”

– QA Manager, Cardiovascular Devices

Ready to Strengthen Your Regulatory Expertise?

Whether you’re an individual professional or need team training, we’ll help you build compliance confidence.

Medical Device Regulatory Training Resources

MDR Consultants Inc. provides medical device regulatory training for FDA QMSR, EU MDR, and ISO 13485 compliance. Developed by Notified Body lead auditors, our expert-led courses empower professionals to meet real-world compliance challenges with confidence.

Our training aligns with the EU MDR 2017/745 and FDA QMSR Final Rule. Need audit support? See our compliance checklists or consulting services.

  • Self-paced online courses with expert support
  • Live virtual training sessions
  • Custom corporate training packages
  • Audit-proven checklists and templates

Based in Miami, Florida, MDR Consultants has helped thousands of medical device professionals advance their regulatory expertise globally.

Quality Management System
ISO Statutory
MDD (European Union)
USA FDA
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)
TGA (Australia)