ISO 14971 Course
Master ISO 14971 for medical devices and wearables. Learn to identify hazards, estimate and control risk, meet MDR/FDA expectations, and build a compliant risk management file that protects patients, supports approvals, and strengthens device safety.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The ISO 14971 Course gives you practical, step-by-step guidance to build a compliant risk management process for wearable heart rate and SpO2 monitors. Learn to define intended use, identify hazards from software, batteries, sensors, and cybersecurity, estimate and prioritize risks, implement and verify controls, document residual risk, and maintain an effective risk management file with strong postmarket surveillance.
Elevify advantages
Develop skills
- Apply ISO 14971: build a compliant risk file for medical wearables fast.
- Analyze device use: capture intended use, misuse, and user profiles clearly.
- Identify hazards: map software, battery, and cybersecurity risks in practice.
- Prioritize risks: design simple matrices, severity scales, and ALARP decisions.
- Implement and verify controls: test safety, usability, and postmarket feedback.
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
FAQ
Who is Elevify? How does it work?
Do the courses have certificates?
Are the courses free?
What is the course workload?
What are the courses like?
How do the courses work?
What is the duration of the courses?
What is the cost or price of the courses?
What is an EAD or online course and how does it work?
PDF Course