Medical Devices Course
This course offers a practical guide to developing compliant medical devices, covering regulatory pathways, risk management, design principles, verification, and data security.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Medical Devices Course provides a quick, hands-on introduction to defining, designing, and bringing to market safe and compliant medical devices. You will learn important regulatory routes in the US and EU, along with ISO 13485 and ISO 14971 standards for risk management. The course covers hardware, software, cybersecurity, usability, clinical assessment, and data protection, helping you confidently turn ideas into approved, dependable products.
Elevify advantages
Develop skills
- Regulatory strategy: outline FDA and EU MDR routes for connected medical devices.
- Risk and safety design: use ISO 14971, FMEA, and controls for wearable devices.
- Hardware and software architecture: create safe, low-power, BLE-enabled monitors.
- Verification and clinical proof: arrange V&V, usability, and efficient clinical assessments.
- Cybersecurity and data privacy: protect PHI using HIPAA/GDPR-compliant 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.What our students say
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