Study Guide

Objectives

The students
- know the government regulations and requirements of health care medical device and software, including the patient safety viewpoint and are able to document them.
- are able to apply regulations in in medical device development.
- know health care technology solutions’ and services’ entire project life cycle.
- know the most common health care technology and software service processes and their production stages.

Content

Medical device and software government regulations and requirements.
Risk management.
Medical device and software regulatory requirements and documentation.
Clinical evaluation and research
Classification criteria of medical devices
Qualitative management systems
Placing medical device and software on the market and CE marking
Services of medical devices and software.