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Medical Devices Course

Medical Devices Course
flexible workload of 4 to 360h
valid certificate in your country

What will I learn?

This course offers a quick, practical guide to defining, designing, and launching safe, compliant medical devices. It covers essential US and EU regulatory pathways, ISO 13485 and ISO 14971 standards, risk management, hardware, software, cybersecurity, usability, clinical evaluation, and data protection, enabling confident progression from concept to market-ready products.

Elevify advantages

Develop skills

  • Regulatory strategy: map FDA and EU MDR paths for connected medical devices.
  • Risk and safety design: apply ISO 14971, FMEA and controls to wearable devices.
  • Hardware and software architecture: design safe, low-power, BLE-enabled monitors.
  • Verification and clinical proof: plan V&V, usability and lean clinical evaluations.
  • Cybersecurity and data privacy: secure PHI with HIPAA/GDPR-aligned controls.

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.
Workload: between 4 and 360 hours

What our students say

I was just promoted to Intelligence Advisor of the Prison System, and the course from Elevify was crucial for me to be chosen.
EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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