Clinical Investigation for Medical Devices and ISO 14155

This course provides a detailed introduction to clinical research for medical devices, covering Good Clinical Practice (GCP) and ISO 14155 guidelines. It outlines the development, regulatory requirements, and risk management of medical devices, as well as the planning, start-up, conduct, and termination of clinical studies. It details the responsibilities of sponsors and investigators and addresses the financial aspects of managing clinical investigations.

Module 1 : Clinical Research of the Medical Devices

  • Introduction to Clinical Research of Medical Devices

Module 3 : How to Study and Market a Medical Device

  • Development of Medical Devices
  • Regulatory Requirements EU MDR 2017-745
  • Clinical Investigations and Risk Management
  • Risk and Clinical Investigation Stages

Module 5 : Clinical Study Start Up

  • Site Selection – Qualification of Sites and Investigators
  • Ethics Committee and Competent Authority Submissions and Agreements
  • Site Initiation

Module 7 : Clinical Study Termination

  • End of Enrolment
  • Site Close Out
  • Clinical Investigation Report

Module 2 : Clinical Practice and ISO 14155

  • What is Good Clinical Practice (GCP)?
  • Who must Follow GCP?
  • ISO 14155 Content, Clauses, and Annexes
  • Major Changes in New Version of ISO 14155

Module 4 : Clinical Study Planning

  • Clinical Investigation Milestones
  • Identifying Stakeholders
  • Developing Essential Documents

Module 6 : Clinical Study Conduct

  • Site Management – Devices, Documents, and Training
  • Safety Reporting
  • Site Monitoring

Module 8 : Summary of responsibilities for clinical investigations

  • Summary of Sponsor Responsibilities
  • Summary of Investigator Responsibilities

Module 9 : Financing and Managing a Clinical Investigation

  • Preparing a Clinical Investigation Budget
  • Financing and Managing a Clinical Investigation
Certificate In FCPM [ Online ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Batches Starting From 

August 2024
Enroll Now For Early Bird Offers
in Both Mode
Certificate In FCPM [ Offline ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play

Get to work on live projects

Face-to-face guidance by PM (Project Manager)

Clinical on-site exposure

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