MDR compliance training
Gain mastery in EU MDR compliance for reusable Class IIb orthopedic devices. Acquire essential knowledge on PMS, PMCF, PSUR, UDI, clinical evidence, and QMS. Transform regulations into practical tools for safer devices, smoother audits, and improved healthcare outcomes.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
MDR Compliance Training offers focused, practical guidance to achieve EU MDR 2017/745 compliance for reusable Class IIb orthopedic drill systems. Delve into fundamentals, clinical evaluation, PMCF, PMS, vigilance, UDI, technical documentation, QMS alignment, and Notified Body expectations. Develop compliant files, design effective internal training, and facilitate seamless transition from MDD to MDR with confidence and efficiency.
Elevify advantages
Develop skills
- Develop MDR device strategy: classify Class IIb orthopedic systems swiftly 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 pass audits.
- Compile technical files: assemble MDR-compliant risk, usability, and sterilisation documentation.
- Achieve Notified Body readiness: prepare 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 lessons are perfect. I purchased 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 supplementary videos really help with learning.

Giulio CarloPrompt Engineering Student
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