Module 15: Clinical Evaluation of Medical Devices

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Covers the broad scope of clinical investigation for medical devices and the regulatory processes required, including alternative routes to demonstrate regulatory compliance.

Overview

This module provides an overview of the clinical research paradigm for medical devices and the key underlying ethical and statistical methodology. It includes the core regulatory requirements that relate to the appropriate performance of devices and analysis of the place clinical evaluation plays in risk analysis and risk management during device development and manufacture.

Students will gain an understanding of the requirements for ethics committee approval and institutional review board (IRB) approval; notification and pre-approval requirements; systematic review in clinical investigation and an understanding of the health technology appraisal systems and reimbursement on clinical evaluation.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Critically evaluate existing literature and assess the need for clinical evaluation
  • Critically evaluate the methodology and conduct of clinical research
  • Appraise the factors that influence the quality of clinical evaluation
  • Demonstrate a systematic understanding and critical awareness of the regulatory requirements, directives and associated documentation relating to the clinical evaluation of medical devices.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to critically analyse the legal documentation relating to clinical evaluation of devices
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to non-specialist audiences
  • Critically appraise and evaluate communications from regulatory bodies and stakeholders relating to the conduct of clinical research.

Developing expertise in all areas of medical devices? Consider:

  • Module 14: Design, Development and Certification of Medical Devices
  • Module 16: Post-Market Surveillance and Vigilance for Medical Devices
  • Module 17: Regulatory Strategy in the Post Market Phase
  • Module 21: US Regulation of Medical Devices

Expanding your options? Consider:

  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 18: Drug-device Combinations and Other Technologies
  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies