Study Guide

Objectives

The student
- masters entirety and documentation concerning the government regulations and requirements of health care medical device and software
- is able to apply regulatory requirements in hardware and software design and product development
- masters the CE marking process for healthcare equipment and software

Content

Healthcare hardware and software requirements
Risk management system
Demonstration of hardware and software compliance
Clinical evaluation and research
Classification criteria
Quality management system
CE marking of healthcare equipment and software

Assessment criteria, satisfactory (1-2)

The student
- is able to describe the medical device regulatory process.
- can prepare a basic level description for the risk management documentation for a medical device
- knows the CE conformity requirements related to medical devices, but cannot assess the detailed classification of a device
- has participated in group project work, but has done their part incompletely.

Assessment criteria, good (3-4)

The student
- is able to describe and prepare a set of regulatory requirements for a medical device
- can prepare a description and analyse the risk management documentation for a medical device
- knows the CE conformity requirements related to medical devices and is able to assess the classification of a device
- has participated in group project work and has done their part well.

Assessment criteria, excellent (5)

The student
- is able to describe, compile and apply a set of regulatory requirements for medical devices
- can prepare a description and analyse and evaluate the risk management documentation for a medical device
- knows the CE conformity requirements related to healthcare devices well and is able to assess and justify whether the device is subject to medical device regulation or not
- has participated in group project work and has done their part excellently.