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
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
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