• 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