EU MDR Responsible Person Training
Master EU MDR Article 15 and the PRRC role. Learn how to review technical documentation, manage audits, oversee risk and clinical evidence, and lead PMS and vigilance so your organization’s Class IIb and Class I devices stay safe, compliant, and market-ready.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
EU MDR Responsible Person Training gives you clear, practical guidance to perform PRRC duties with confidence. Learn Article 15 requirements, technical documentation, device release controls, risk management, clinical evidence, and post‑market surveillance, plus how to handle audits, vigilance reporting, change control, and governance so you can safeguard compliance and support safe, compliant devices.
Elevify advantages
Develop skills
- Apply Article 15 MDR: define PRRC duties, qualifications, and daily decisions.
- Build compliant MDR technical files and sign device release with confidence.
- Lead Notified Body audits and respond to findings with robust CAPA evidence.
- Manage MDR risk, design changes, and clinical evidence for Class IIb devices.
- Oversee PMS, vigilance, and PRRC governance to protect patients and liability.
Suggested summary
Before starting, you can change the chapters and 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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