Medical Devices Course
Gain expertise in the complete lifecycle of medical devices for healthcare, covering FDA and EU MDR regulatory pathways, ISO standards, risk management, hardware and software design, cybersecurity, and clinical evaluation to deliver safe, compliant innovations to patients effectively.

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.What our students say
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