Course overview

Clinical evidence is crucial to bringing a device to market and is a very important aspect of post-market compliance to meet the requirements of current legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.

This practical and intensive two-day course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices. It will cover the full range of activities that should be applied during the collection of clinical evidence for both pre- and post-market studies and will also provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies. Participants will benefit from advice and tips from industry experts on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant with the new MDR.

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.

Benefits of attending

Understand the regulatory requirements and guidance applicable to clinical evidence
Clarification on Clinical Evaluations (Literature Reviews)
Understand what is required in terms of clinical data prior to CE marking and post CE mark
Know what documentation is needed for the pre-and post-market phases of clinical data collection
Discover how to conduct a clinical investigation and post market clinical follow-up study
Plan how to prepare regulatory notifications to the competent authorities and obtain other necessary approvals
Understand the key aspects of pre and post market study setup, management, monitoring and close down
Discuss how to prepare a paper or presentation for publication and marketing
Understand the differences between drugs and devices

Who should attend

Personnel involved in setting up, managing and monitoring studies
Setting up, managing and monitoring studies
R&D
Marketing
Regulatory Affair
Those who conduct clinical evaluations/investigations/post market follow up studies
Those moving from Pharma to Medical Device studies

Enrol or reserve

This course will cover:

Day 1
Day 2

The regulatory aspects of gathering clinical evidence for devices

An overview of the regulations governing the clinical evidence aspects of devices
How the regulations impact on clinical data for regulatory studies and post market studies
Standards and guidelines applicable to medical device clinical evidence, ISO, GHTF (IMDRF), MEDDEV and NBMED

Conducting a pre-market clinical evaluation and the literature review

The Clinical Evaluation (Literature Review)
What’s involved and how it should be conducted
What documents are required – how is clinical data used?
Example documents and templates will be provided to help delegates understand this process

Conducting a pre-market (regulatory) clinical investigation

What types of studies and study designs are applicable to pre-market studies?
What to consider in designing and implementing appropriate pre-market studies

Documentation for pre-market (regulatory) clinical investigation

What documentation is needed?
How this should be produced and what detail is required
This presentation will include template documentation for clinical investigation plans, investigator brochures, case report forms and consent forms

How to obtain the necessary approvals for pre-market studies

How to obtain Research Ethics approval
How to obtain National competent authority approvals
Other necessary approvals
What to provide, timescales and practicalities

Study management and monitoring of regulatory clinical investigation

Key aspects study set up
Management, monitoring and close down
Getting the best data

How to write a final study report for a regulatory clinical investigation pre-market study

Practical considerations for final study reports, publications and presentations of study results
Examples and templates will be provided to help delegates understand the processes
How to prepare a paper or presentation for publication and marketing

PMCF

Practical considerations for conducting PMCF studies
The differences between PMCF and regulatory studies
When to conduct PMCF studies and other PMC data requirements

Current key issues affecting clinical evidence for medical devices

The effect of changes to the directives and current initiatives throughout Europe

The differences between drugs and devices

Enrol or reserve

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

11-12 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 14018

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

Until 07 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

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* 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.