Medical Devices Course
This course offers a practical guide to developing compliant medical devices, covering regulatory pathways, risk management, design principles, and security standards to bring safe products to market.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
The Medical Devices Course provides a quick, practical overview of how to define, design, and launch safe, compliant devices. Learn key US and EU regulatory pathways, ISO 13485 and ISO 14971, risk management, and essential standards. Explore hardware, software, cybersecurity, usability, clinical evaluation, and data protection so you can move from concept to approved, reliable products with confidence.
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.What our students say
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