Presented by
Management Forum

Medical Device Studies: Clinical Evidence

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

9-10 May 2022 + 2 more dates

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

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.

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

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The Medical Device Studies: Clinical Evidence course will cover:

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 Researth 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

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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 Medical Device Studies: Clinical Evidence Live online/Classroom training

9-10 May 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11646

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

Until 04 Apr

In your basket 

15-16 Aug 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11427

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

Until 11 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 

14-15 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 11783

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

Until 10 Oct

In your basket 

Reviews of IPI's Medical Device Studies: Clinical Evidence training course


Very good course ! It worked very well to have it online and be able to see the speaker and the presentation at the same time!

Nov 9 2020

Christa Myhre
RA Specialist, Radiometer Medical Aps

Nov 9 2020

Very good course! It worked very well to have it online and be able to see the speaker and the presentation at the same time!

Christa Myhre
RA Specialist, Radiometer Medical Aps

May 13 2019

This course was extremely helpful and relevant. The trainers were very knowledgeable and experienced.

Jessica Allen
Regulatory Affairs Specialist, JRI

Nov 14 2019

I appreciated the interactive way of presenting and the incorporation of questions and examples. I learned a lot.

Sandra Tobisch
Clinical Trial Manager, BSN medical GmbH / Essity

Nov 14 2019

A very interesting course, good for networking. Speakers were very prepared and good in enhancing discussions.

Barbara Acca
CRA Lead/ CTM, Cepheid

May 16 2018

I got what I needed. Theory and practical examples, Thank you!

Karmela Kopcic
Senior Associate for Medical Devices, Croatian Agency for Medicinal Products and Medical Devices (HALMED)

Nov 14 2018

Great knowledge within the area of clinical studies and MDs. Interactive and willing to share their knowledge and experience. Entertaining to listen to, I never got bored despite listening for 2 days. Great!

Anne-Christine Nilsson
COO, Glycobond

Nov 14 2018

Great course to give an overview of a very big topic

Louise Corcoran
Director of Quality and Regualtory Affairs, FIRE1

May 16 2018

Very well organised. Speaker is really experienced and knows how to teach in a friendly manner.

Diana Villanueva
Project Manager, Precision for Medicine

May 16 2018

I got what I needed. Theory and practical examples, Thank you!

Karmela Kopcic
Senior Associate for Medical Devices, Croatian Agency for Medicinal Products and Medical Devices (HALMED)

May 16 2018

Excellent

David Browne
Development Technician, Biovotec

Nov 14 2018

Overall it was a great opportunity to get more awareness on clinical studies with medical devices. The documentation provided was very clear and provided valuable input for setting procedures in my company. The speakers were very open to interaction and there was enough time for discussion. The combination with hands-on tasks was also key to understand the content.

Ricardo De Sa
Regulatory Affairs Manager, Definiens AG

Nov 14 2018

For me the course content was pitched well for the time allowed. I thought the presenters did a great job of managing the participants expectations.

Stephen Rowe
Managing Director, SGR Consulting Services Ltd

May 16 2018

Very experienced and knowledgable [speakers]. Excellent.

Dawn Chesher
Regulatory Affairs Director Consumer Healthcare, GlaxoSmithKline (GSK)

May 16 2018

I am very happy about the training, the atmosphere and the venue. Janette was great and very friendly.

Sébastien Malaise
R&D Manager, Sinclair

Nov 29 2017

Effective overview of clinical investigation, quite intensive

Gianluca Colucci
In-House Clinician, Intertek

Nov 29 2017

Very useful course with excellent speakers

Suna Horner
Associate Medical Manager, HRA Pharma UK & IE Ltd.

Nov 29 2017

Knowledgable speakers

Faye Murray
Product Manager Diagnostics, Owen Mumford Ltd

May 9 2017

Excellent, really enjoyed the course.

Jenny Nilsson
Medical Co-ordinator, Glycorex Transplantation AB

May 9 2017

Great course - ticked all the boxes I had - would definitely recommend it to anyone starting out in this field - only wish I'd known about this and the other courses you offer earlier

Julia Herbert
Clinical Director, Femeda Ltd.

Nov 29 2017

This course was very beneficial for me. Overall the information given and the way the speakers shared that information was very satisfactory.

Marguerite Rizkallah
MD Regulatory Affairs Manager, Benta SAL

Nov 29 2017

Gives a good overview and interesting discussions. Lots of uncertainties in the business but good to discuss

Åsa Odhagen Rosvall
Evidence Strategist, Mölnlycke

Nov 29 2017

Open, knowledgable and clear with good detail

Mina Patel
RA Manager, Medtrade Products Limited

Nov 29 2017

Good overall overview of clinicals

Julie Eyers
Regulatory Affairs Manager, Boston Scientific

Nov 22 2016

the course was excellent, due to small group size (9+2) discussion and interaction with presenters and participants was possible all the time and also allowed customising of its content. A stimulating meeting.

Mirko Hechenberger
Regulatory Affairs Manager, Merz Pharmaceuticals GmbH

May 11 2016

Overall, it was a really good course and the speakers were really good as well

Sandra Beltran-Rodil
Manager, Regulatory Affairs , TEVA UK Ltd

May 11 2016

I really enjoyed my two days. I am much clearer on my understanding of the Clinical requirements for a medical device and the sequence of events and steps that need to be followed.

Priti Darjee
Associate Director Regulatory Affairs, UK, Teva UK Ltd

Nov 22 2016

Content was good within the objectives of the course. Well presented. Good speakers

Teresa Lopes
Manager Medical Devices, BioTop Medical

Nov 22 2016

This is the best course I have attended for a long time! Well done!

Phil Rosher
Head of Regulatory Affairs, Dermal Laboratories Ltd

Nov 22 2016

Course was tailored to suit the needs to the the group. And personal requests were taken into account. Presentation was good, and broken up into easy digestible parts

Tony Wilson
Clinical Research Associate, Biomet UK Healthcare Ltd

UK

  • Allergan
  • Allergan UK Limited
  • BBI Solutions
  • Biogen Idec Ltd
  • Biomet UK Healthcare Ltd
  • Cepheid
  • Cerapedics Inc.
  • CROMSOURCE
  • DePuy Synthes
  • Dermal Laboratories Ltd
  • Ekso Bionics
  • Emergo Consulting (UK) Ltd
  • Femeda Ltd.
  • GlaxoSmithKline (GSK)
  • HRA Pharma UK & IE Ltd.
  • ICR
  • Intertek
  • Invibio Ltd
  • JRI
  • King's College
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medigen Regulatory Limited
  • Medtrade Products Limited
  • Owen Mumford Ltd
  • Precision for Medicine
  • Proprietary Association of Great Britain
  • Quanta Dialysis Technologies Ltd
  • Research Instruments Ltd
  • Sestria Ltd
  • SGR Consulting Services Ltd
  • Sinclair
  • SPD Development Company Limited
  • TEVA UK Ltd
  • Thornton & Ross Ltd
  • Tissue Regenix Ltd
  • Zimmer Biomet

Denmark

  • Alk Abello A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • ORIGIO
  • Radiometer Medical Aps
  • SSI Diagnostica
  • Unomedical
  • Unomedical a/s - A Convatec Company

Sweden

  • Atos Medical
  • Atos Medical AB
  • Euro-Diagnostica
  • Glycobond
  • Glycorex Transplantation AB
  • Mölnlycke

Spain

  • iLine Microsystems S.L
  • Almirall S.A
  • Casen Recordati SL
  • ISDIN
  • Laboratorios CINFA SA

Switzerland

  • FIND
  • Geistlich Pharma
  • GSK Consumer Health
  • Institut Straumann AG
  • Nobel Biocare Services AG

Germany

  • BSN medical GmbH / Essity
  • Definiens AG
  • Grunenthal GmbH
  • Merz Pharmaceuticals GmbH

Ireland

  • Biovotec
  • Boston Scientific
  • FIRE1
  • Veryan Medical Ltd

France

  • Air Liquide Santé International
  • Biosphere Medical SA
  • Urgo Laboratoires

Netherlands

  • BioTop Medical
  • Omron Healthcare Europe BV

New Zealand

  • Fisher & Paykel Health Care
  • Fisher & Paykel Healthcare

Belgium

  • Terumo BCT

Croatia

  • Croatian Agency for Medicinal Products and Medical Devices (HALMED)

Italy

  • Abiogen Pharma S.p.A.

Lebanon

  • Benta SAL

Saudi Arabia

  • Saudi Food and Drug Authority

United States of America

  • USGI Medical

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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