MDR compliance training
Gain expertise in EU MDR compliance for reusable Class IIb orthopedic devices. Master PMS, PMCF, PSUR, UDI, clinical evidence, and QMS requirements, transforming regulations into practical strategies for safer devices, seamless audits, and improved healthcare results.

from 4 to 360h flexible workload
certificate valid in your country
What will I learn?
MDR Compliance Training offers targeted, practical advice to comply with EU MDR 2017/745 for reusable Class IIb orthopedic drill systems. Cover essentials like clinical evaluation, PMCF, PMS, vigilance, UDI, technical documentation, QMS alignment, and Notified Body requirements. Develop compliant documentation, effective internal training programmes, and facilitate smooth MDD to MDR transition 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 pass audits.
- Compile 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
As suas aulas são perfeitas. Adquiri o pacote de um ano e, finalmente, tenho a oportunidade de acompanhar diversos temas do meu interesse sem precisar mudar de plataforma... agradeço por tudo o que fazem, já recomendei vocês a outras pessoas...

Giulio CarloAluno de Marketing Digital
Eu gosto de como as lições são direto ao ponto e como eu consigo alterar capítulos e pular conteúdos que não preciso.

Mariana FerresAluna de Fotografia
Gosto do conteúdo e do modo de apresentação e transcrição de vídeos, o que acelera o processo!

Luciana AlvarengaAluna de Design de Unhas
A plataforma é rápida, simples de usar. A diversidade de conteúdo e os vídeos complementares ajudam muito no aprendizado.

Giulio CarloAluno de Engenharia de Prompt
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