Medical Devices Course
Gain mastery over the complete medical device lifecycle in healthcare, covering FDA and EU MDR regulations, ISO standards, risk assessment, hardware and software design, cybersecurity, and clinical validation. This equips you to deliver safer, fully compliant innovations that improve patient care across markets.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This course offers a quick, hands-on guide to defining, designing, and launching safe, compliant medical devices. You'll cover major US and EU regulations, ISO 13485 and ISO 14971 standards, risk management, and key requirements. Dive into hardware, software, cybersecurity, usability, clinical testing, and data security to confidently turn ideas into approved, trustworthy products.
Elevify advantages
Develop skills
- Develop regulatory strategies mapping FDA and EU MDR pathways for connected medical devices.
- Apply ISO 14971, FMEA, and safety controls to design risks for wearable health tech.
- Design secure hardware and software architectures for low-power, BLE-enabled monitoring devices.
- Plan verification, validation, usability testing, and efficient clinical evaluations.
- Implement cybersecurity and data privacy measures aligned with HIPAA and GDPR for patient information.
Suggested summary
Before starting, you can change the chapters and 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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