Study Guide

Objective

After completing the course the student:
- is familiar with legislation and regulatory bodies that play a key role in product development of medical devices
- is able to designate commonly used standards for product development in medical devices and understand their importance in product development
- understands the purpose and requirements for risk management process
- understands the purpose and impact of the quality management system for product development

Content

- Legislation and regulations on medical device product development
- Product development standards
- Risk management
- Quality system
- Software as a medical device

Evaluation scale

H-5