MDR compliance training
Gain mastery in EU MDR compliance for reusable Class IIb orthopedic devices. Delve into PMS, PMCF, PSUR, UDI, clinical evidence, and QMS essentials. Transform regulations into practical tools for safer devices, seamless audits, and improved healthcare results.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
MDR Compliance Training delivers targeted, practical advice to satisfy EU MDR 2017/745 for reusable Class IIb orthopedic drill systems. Master the basics, clinical evaluation and PMCF, PMS and vigilance, UDI, technical documentation, QMS alignment, and Notified Body requirements. Construct compliant files, craft effective internal training, and ensure smooth shift from MDD to MDR with assurance and efficiency.
Elevify advantages
Develop skills
- Develop MDR device strategy: classify Class IIb orthopedic systems quickly and accurately.
- Master clinical evidence planning: create efficient CEP and PMCF for reusable drill systems.
- Implement PMS and vigilance: establish PMS plans, PSURs, and incident reporting to ace audits.
- Assemble technical files: prepare MDR-compliant risk, usability, and sterilization documentation.
- Achieve Notified Body readiness: organise files, handle audits, and uphold MDR compliance.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
Your classes are perfect. I got the one-year package and finally have the chance to follow several topics I'm interested in without having to switch platforms... thank you for everything you do, I've already recommended you to others...

Giulio CarloDigital Marketing Student
I like how the lessons get straight to the point and how I can switch chapters and skip content I don't need.

Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the extra videos really help with learning.

Giulio CarloPrompt Engineering Student
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