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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

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

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1-2 Dec 2021

& 1-2 Feb 2022 , 4-5 May 2022 , 8-9 Aug 2022 , 28-29 Nov 2022

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Details

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

Programme

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

Presenter

Janette Benaddi (More...)

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.

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Book now

1-2 Dec 2021
Live webinar
1-2 Dec 2021
Live webinar 		GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 27 Oct* 		Enrol now
to attend
Live webinar
1-2 Feb 2022
Face-to-face, (venue not yet confirmed)
1-2 Feb 2022
Face-to-face
(venue not yet confirmed) 		GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 28 Dec* 		Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
4-5 May 2022
Live webinar
4-5 May 2022
Live webinar 		GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 30 Mar 22* 		Enrol now
to attend
Live webinar
8-9 Aug 2022
Face-to-face, (venue not yet confirmed)
8-9 Aug 2022
Face-to-face
(venue not yet confirmed) 		GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 4 Jul 22* 		Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
28-29 Nov 2022
Live webinar
28-29 Nov 2022
Live webinar 		GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 24 Oct 22* 		Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • AbbVie
  • AO Foundation
  • Astellas
  • Barco NV
  • Bedfont Scientific
  • BioTop Medical
  • CROMA-PHARMA GmbH
  • Current Health
  • Demant
  • EduBroker Sp.zo.o
  • Fresenius Medical Care D-GmbH
  • Guerbet
  • Gulf Health Council
  • Luzmon Medical AS
  • MED-EL Elektromedizinische Geraete
  • Med-El Elektromedizinische Geraete Gesellschaft m.b.H.
  • MED-EL Elektromedizinische Geräte GmbH
  • Medigen Regulatory Limited
  • Medstrom Ltd
  • Novo Nordisk
  • Novo Nordisk A/S
  • Q-Med AB
  • RaLex Consulting
  • Red Line Pharmacovigilance
  • Research Instruments Ltd
  • Rontis AG
  • RSP Systems A/S
  • Saudi Food and Drug Authority
  • Sinclair Pharma
  • UPM-Kymmene Corporation

“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 21

“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.”

Juliana Pugmire, Clinical Research Consultant, Current Health, Jun 21

“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, Jun 21

“ Everything was perfect.”

Amnah AlKhan, Regulatory Affairs Specialist, Gulf Health Council, Dec 20

“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 19

“Eveything perfect!”

Katarzyna Paluszynska, Clinical Associate, EduBroker Sp.zo.o, Nov 19

“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, Nov 19

“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 19

“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, Nov 19

“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, Jun 19

“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 19

“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 19

“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, Dec 18

“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 18

“Expected content, clear presentation, very approachable speaker”

Teresa Lopes, Manager Medical Devices, BioTop Medical, Dec 18