• Classroom
  • Online, Instructor-Led
Course Description

The Medical Device Test and Evaluation Course provides a comprehensive understanding of the principles and practices involved in testing and evaluating medical devices for safety, efficacy, and regulatory compliance. This course covers a range of testing methodologies, standards, and regulatory requirements specific to medical devices. Through theoretical knowledge, hands-on exercises, and case studies, students will gain the skills necessary to perform thorough testing and evaluation of medical devices, ensuring their reliability, functionality, and adherence to regulatory guidelines.

Learning Objectives

  • Understand the regulatory framework governing medical device testing and evaluation.
  • Examine the different phases of medical device development and the associated testing requirements.
  • Explore the principles and methodologies of risk assessment in the context of medical devices.
  • Learn the fundamentals of usability testing for medical devices to ensure user safety and effectiveness.
  • Gain insights into the validation and verification processes for medical device performance and reliability.
  • Understand the importance of clinical trials in evaluating the safety and efficacy of medical devices.
  • Explore the role of quality management systems in the testing and evaluation of medical devices.
  • Examine the ethical considerations and regulatory compliance involved in medical device testing.
  • Acquire practical skills in conducting various tests and assessments for different types of medical devices.
  • Develop critical thinking and problem-solving abilities in the context of medical device testing challenges.

Framework Connections

The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):

Specialty Areas

  • All-Source Analysis
  • Vulnerability Assessment and Management
  • Risk Management
  • Threat Analysis
  • Test and Evaluation