Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

New course for 2018

5-6 Jun 2019

& 26-27 Nov 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

  • Gain a detailed overview of the clinical evaluation process
  • Understand the concepts involved in conducting a clinical evaluation
  • Learn how to utilise information gathered during a clinical evaluation
  • Understand where clinical evaluation fits in the development and marketing of medical devices
  • Take away skills in conducting systematic literature searches
  • Learn how to appraise data
  • Know how to assemble clinical evidence acceptable for review by Regulatory Authorities or Notified Bodies

Why you should attend

This two day course will cover all the aspects of clinical evaluation in line with the European Medical device regulations and applicable guidance documents. The course will provide you with the tools and skills you will need to produce a high quality clinical evaluation report for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a clinical evaluation report that is acceptable to the Regulatory Authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post market aspects of clinical evidence. The course includes case studies and template documents which you will be able to utilise to produce your own high quality clinical data evidence documentation.

Who should attend

  • CROS
  • Medical writers
  • Personnel involved in:
    • Gathering clinical evidence and conducting clinical evaluations
    • R&D
    • Clinical staff
    • Regulatory affairs
  • Those who conduct clinical evaluations/investigations/post-market follow up studies
  • Those moving from Pharmaceuticals to Medical Devices

Programme - Day one

Objectives and overview

What is a clinical evaluation?

  • Explanation of the terminology used in clinical evalutions
  • Overview of what a clinical evalution is
  • The importance of clinical evidence in medical device development

Why and when is it necessary to conduct a clinical evaluation

  • Where does clinical evaluation sit within the medical device process
  • Why is clinical evidence important
  • Who are the stakeholders in the process

Who and what is involved in the clinical evaluation process

  • Overview of each step
  • Use of equivalent products

Workshop : Bringing it together

  • An interactive exercise on what has been learnt so far

What regulations govern clinical evaluations and what guidance documents should clinical evaluations be conducted to

  • An in depth review of the available regulatory and guidance documents which can be utilised during the process and how to interpret these

Quiz

Q & A and wrap up of day one

Programme - Day two

Review of day one, introduction to the day, objectives and overview

Documentation necessary for conducting a clinical evaluation

  • The clinical evaluation plan

The literature review process

  • Selecting databases and conducting searches
  • How to source data and review it
  • How to clarify the question on which you need to find literature, including devising the most comprehensive literature search strategy and selecting key words

The Clinical Evaluation Report (CER)

  • What is it and what is included
  • Who should write it
  • How to write it and what is included

What is state of the art and how to conduct a risk benefit assessment of the data

  • Performance and safety analysis
  • State of the art analysis
  • Risk benefit analysis

Impact of the Medical Device Regulations (MDR)

  • What do Notified Bodies (NB) look for when reviewing the report
  • How to meet NB expectations
  • Quality assurance steps for the final CER

Quiz

Q & A and wrap up

Presenter

Janette Benaddi (5-6 Jun 2019)

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

Book now

5-6 Jun 2019
5-6 Jun 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
26-27 Nov 2019
26-27 Nov 2019 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Astellas
  • Biotop Medical
  • Fresenius Medical Care D-GmbH
  • Luzmon Medical AS
  • MED-EL Elektromedizinische Geraete
  • Nobel Biocare Services AG
  • RaLex Consulting
  • Red Line Pharmacovigilance
  • Rontis AG