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Good People Working on Good Projects with Good Process

Writing Clinical Evaluation Reports (CER) – Beginner

October 24, 2019 (4 hrs) $325.00

Course Description

This Frestedt Learning Center (FLC) course is a 4-hour session designed for new CER writers and team members which will include a basic overview of the “Guidelines on Medical Devices – Clinical Evaluations: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC” (MEDDEV 2.7/1, Rev 4) guideline issued in June 2016. In addition, the upcoming Medical Device Regulations (MDR) related to CERs will be introduced as these will be enforced by all Notified Bodies in 2020. In this interactive program, participants with 0-3 years of experience working on CERs will have the chance to discuss challenges they have experienced in writing CERs. CER writing is a growing professional endeavor since all marketed devices are required to have a CER.

Benefits to Your Business

  1. Provide introductory training to CER team members
  2. Develop an understanding of MEDDEV 2.7/1 and the new MDR related to CERs
  3. Begin a program for staff development in CER writing

Learning Objectives

On completion of this training, participants will be able to:

  • Understand what a CER is
  • Be familiar with the MEDDEV 2.7.1, Rev 4 guideline and MDR 2020
  • Describe a “suitably qualified individual or team” to develop the CER
  • Identify key tasks or steps needed to complete the CER
  • Be familiar with Notified Bodies and their purpose
  • Identify the participants specific roles in CER development

Intended Audience

  • CER Writing/Reporting Specialists
  • Regulatory Affairs Specialists/ Managers/ Directors
  • CER Team Members
  • Clinical Nurse Specialists
  • Project Managers
  • Post Market Surveillance Managers
  • Clinical Data Specialists/ Analysts/ Managers
  • Evaluation and Research Directors
  • Technical Communication Specialists/ Medical Writers
  • Clinical Education Specialists
  • Clinical Affairs Specialists/ Managers/ Directors
  • Corporate Librarians

CER Writing custom training may also be tailored to individual business needs; duration and price will vary.

Agenda (CST)

8:00am-8:30am

Arrive and Register

8:30am-8:45am

Introduction

8:45am-10:30am

Intro to CERs, CER requirements, steps in CER writing.

10:30am

Mid-morning break

10:45am-12:15pm

Steps in CER writing, Writing the CER, Intro to Notified bodies

12:15pm-12:30

Wrap-Up and Q&A

Prerequisites

None

To book this course or set up a custom training, call 952-426-1747 or email info@frestedt.com.