Introduction to Clinical Research with Medical Devices

 

Introduction to Clinical Research with Medical Devices

Clinical Research Related Courses

Do you want to understand the rules and legislation in clinical research with medical devices? This one-day course is especially designed to let you understand European legislation, the classification and the CE marking of medical devices. You get to understand ISO14155 and safety reporting in a practical way.

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850,00 €
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Full description

This one day course is designed to introduce the fundamental concepts and regulatory requirements of clinical trials with medical devices.
Topics include definition and classification of different types of medical devices, introduction to medical device regulations in Europe and in the US, the medical devices directive and the current ISO 14155 standard. Contents and requirements of the investigator’s brochure and the investigational
plan will be described.
Participants will learn about the implementation of the latest directives and MEDDEVS, ruling the pathway of CE marking. In addition, an overview of the European requirements regarding safety reporting will be presented.

Who should attend?

Everyone involved in clinical research and regulatory affairs in the medical device industry, including pharmaceutical and medical device companies,
contract research organizations, investigators, site personnel.

Trainers
  • Definitions and classification of medical devices
  • Overview of European and US medical device regulatory requirements
  • The ISO 14155 standard
  • Safety reporting requirements in the European Union
  • Differences between drug and device clinical trials
  • To differentiate between various types of medical devices
  • To understand CE marking
  • To know about European and US medical device legislation
  • To comprehend the ISO 14155 standard
  • To identify documentation requirements specific to medical devices
  • To have an overview of safety reporting in the European Union
  • To recognize differences between drug and device development