Presented by
Management Forum

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

1-2 Dec 2021 + 4 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

This two-day introductory course will cover all aspects of clinical evaluation in line with the European Medical Device Regulation (MDR) and applicable guidance documents. The programme will provide you with the tools and skills you will need to produce a high-quality clinical evaluation report (CER) 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 CER 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 programme includes case studies and template documents which you will be able to utilise to produce your own clinical data evidence documentation.

Benefits of attending:

  • 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
  • Take away skills in conducting systematic literature searches
  • Understand where clinical evaluation fits into the development and marketing of medical devices
  • Learn how to appraise data
  • Know how to assemble clinical evidence acceptable for review by regulatory authorities or Notified Bodies

Who should attend

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

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The Clinical Evaluation of Medical Devices: The Clinical Evaluation Report course will cover:

What is a clinical evaluation?

  • Explanation of the terminology used in clinical evalutions
  • Overview of a clinical evalution
  • 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

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 CER

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

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 MDR

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Janette Benaddi

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.

More details

Book Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Live online/Classroom training

1-2 Dec 2021

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 10985

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 27 Oct

In your basket 

1-2 Feb 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11849

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 28 Dec

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

4-5 May 2022

Live online

09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Course code 11677

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 30 Mar

In your basket 

8-9 Aug 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11850

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 04 Jul

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

28-29 Nov 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11793

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 24 Oct

In your basket 

Reviews of IPI's Clinical Evaluation of Medical Devices: The Clinical Evaluation Report training course


I thought this was a terrific webinar, lead by an excellent topic expert, and I feel much more confident about participating and/or leading the CER update at my company.

Jun 8 2021

Juliana Pugmire
Clinical Research Consultant, Current Health

Jun 8 2021

Janette is very nice and friendly. She has a lot of relevant knowledge and experience about the clinical evaluation process and the report. I learned a lot form her!

Dror Sever
Senior Device Information Scientist, Novo Nordisk

Jun 8 2021

It was overall a very good webinar that gave a nice overview of the Clinical Evaluation proces. A shame it had to be a webinar due to the Covid-19 situation, it would have worked better if we could all meet in person and also have small conversations in breaks and so on.

Christina Frary
research audiologist, Demant

Dec 1 2020

Everything was perfect.

Amnah AlKhan
Regulatory Affairs Specialist, Gulf Health Council

Nov 26 2019

Eveything perfect!

Katarzyna Paluszynska
Clinical Associate, EduBroker Sp.zo.o

Nov 26 2019

Janette is excellent. Her knowledge and ability to clearly communicate in an engaging way about the topic at hand really mean that it's very easy to learn and understand what is being discussed. The workshops were very useful in cementing what you've learnt and also bouncing ideas around. Absolutely excellent, fantastic speaker, wealth of knowledge, discussion welcomed!

Alex Hyde
Senior Regulatory Affairs Specialist , Sinclair Pharma

Nov 26 2019

Wonderful speaker, friendly and approachable. He manages to put a lot of information over in a short period, in a simple way, making it a lot easier to digest. Overall, an amazing teacher and incredibly knowledgeable in regulations concerning medical devices. I particularly liked the interaction and encouragement of the group activities and communication. An amazing course, well structured, and a knowledgeable, friendly and approachable speaker.

Hannah Vince-Drew
Clinical Research Associate, Bedfont Scientific

Jun 5 2019

Communication very clear. Immense knowledge and experience. Entertaining. Very open re. questions. Made everybody feel well and acknowledged. Able to create team spirit. Structured. Kept time. Good flow. Fantastic overview with an eye on the details. What's not to like :)

Lise Bruun Hansen
Lead Clinical Audiologist, Demant a/s

Jun 5 2019

Very good teacher. No doubt that she knows what she is talking about and I got more out of the training than I had hoped for. I really liked that we were so few people attending the training, so there was plenty of time to asking questions and discuss the topics.

Karen Elise Karlsmose Boel
Head of Clinical Audology and Usability, Demant a/s

Jun 5 2019

Janette was both very proficient regarding CE both also a lively and engaging presenter. It was a very good course, both content and duration was great

Per Videbæk
Team Manager Clinical Audiology, Demant a/s

Nov 26 2019

The speaker was very knowledgeable, able to answer all questions and allowed time for discussion of everyone's experiences. I learnt a lot and feel it was definitely worth the time.

Alice Sugden
Clinical Trials Submissions, AbbVie

Nov 26 2019

The content is quite comprehensive, the presentation is clear and the speaker is very experienced. Both newbies and experienced people can benefit from this course, especially at the time of MDR transition.

Huajie Bu
Clinical Evaluations Manager, MED-EL Elektromedizinische Geräte GmbH

Dec 6 2018

Very efficient course, explanations were clear in a rather unclear (!) topic, interaction between speaker and attendees promoted the exchange of experiences and opinions. The speaker was well-informed, conveyed the information efficiently. There was a team spirit in dissecting the different aspects of the course's subject. A successful two-day seminar worth of attending.

Athanassios Vratimos
International Product Manager, Rontis AG

Dec 6 2018

Expected content, clear presentation, very approachable speaker

Teresa Lopes
Manager Medical Devices, BioTop Medical

Dec 6 2018

Janette was very patient and professional. She allowed the group to share ideas and engage with each other well. I thought she recognised that on this particular occasion the group engagement was positive and she adapted the course to accommodate interactive discussion. Highly recommend this one.

Shirley-Ann van der Spuy
Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd

UK

  • AbbVie
  • Bedfont Scientific
  • ConvaTec
  • Current Health
  • Medigen Regulatory Limited
  • Medstrom Ltd
  • Norgine
  • Red Line Pharmacovigilance Ltd
  • Research Instruments Limited
  • Sinclair Pharma
  • Vascutek Ltd

Denmark

  • Demant
  • Demant a/s
  • Ferring Pharmaceuticals A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Oticon
  • RaLex Consulting
  • RSP Systems A/S

Switzerland

  • Alexion Pharma GmbH
  • AO Foundation
  • Nobel Biocare Services AG
  • Rontis AG

Austria

  • CROMA-PHARMA GmbH
  • MED-EL Elektromedizinische Geraete
  • MED-EL Elektromedizinische Geräte GmbH

Netherlands

  • Astellas
  • BioTop Medical

Saudi Arabia

  • Gulf Health Council
  • Saudi Food and Drug Authority

Belgium

  • Barco NV

Finland

  • UPM-Kymmene Corporation

France

  • Guerbet

Germany

  • Fresenius Medical Care D-GmbH

Norway

  • Luzmon Medical AS

Poland

  • EduBroker Sp.zo.o

Singapore

  • Merit Medical Singapore Pte Ltd

Sweden

  • Q-Med AB

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy