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Management Forum

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

5-6 August 2024
+ 27-28 November 2024 »
from £1099

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

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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 receive direction on producing 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

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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:

Day 1
Day 2

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 Clinical Evaluation Report (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 Medical Device Regulations (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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5-6 August 2024

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13855

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 01 Jul

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

27-28 November 2024

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 14030

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 23 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.