INTRODUCTION

This one-day online training course is to provide an in-depth understanding of the Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice to assist sponsors, investigators, ethics committees, clinical research professionals and other stakeholders involved in the conformity assessment of medical devices.

This training aims to help participants in understanding the scope and use of ISO 14155:2020 in complying with the Medical Device Regulations. 

The training provides standard guidance to medical device manufacturers and clinical research professionals for how to implement Good Clinical Practice (GCP) for pre- and post-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. Certificate of attendance will be given to the participants.

OBJECTIVES

  • To provide an overview and interpretation of the clauses of ISO 14155:2020
  • To understand the scope and use of ISO 14155:2020 in meeting the requirements of Medical Device Regulations
  • To highlight the importance of ISO 14155:2020
  • To improve the understanding of the requirements of ISO 14155:2020

TARGET AUDIENCE

  • Medical device manufacturers;
  • Quality managers and regulatory affairs personnel;
  • Other Medical Device Industry players;
  • Clinical Research Professionals;
  • Anyone involved with the implementation of the ISO 14155:2020 standard; and
  • Interested individuals.

 

 

 

 

 

 

 

 

Updated: 3rd August 2023