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Medical Device Studies: Clinical Evidence In-house Training

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

★★★★★ "I thoroughly enjoyed the 2 days and speaker is great. Although I am familiar and experienced in some... more (35)"

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Format: Bespoke training
CPD: 12 hours for your records (depending on your requirements)
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.

This course is part of our range of Medical Devices training courses

Benefits of attending

Understand the regulatory requirements and guidance applicable to clinical evidence
Clarification on Clinical Evaluations (Literature Reviews)
Know what is required in terms of clinical data prior to CE marking and post CE mark
Explore 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
Learn 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
See 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 affairs
Those who conduct clinical evaluations/investigations/post market follow up studies
Those moving from pharma to medical device studies

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

I thoroughly enjoyed the 2 days and speaker is great. Although I am familiar and experienced in some of the areas covered, I still felt that I learnt new things. The Workshops were good and it was nice with only 4 of us on the course. I enjoyed the whole webinar a lot.

Oct 15 2025

Jennine Walker United Kingdom
Clinical Affairs Manager, Dermal Laboratories Ltd

Jul 12 2023

The presenters were incredibly knowledgeable in their subject areas and was able to convey complex information, in an easily digestible way. Overall, a very good summary of Clinical evidence for medical devices.

Hannah Vince-Drew United Kingdom
Clinical Research Supervisor, Bedfont Scientific

Nov 24 2022

Janette is a very good speaker; she is very prepared and provided lots of contents and information during these 2 days.

Giulia Carli United Kingdom
Global Clinical Affairs Programme Manager, Corin Ltd

Nov 24 2022

Good knowledge and information provided

Valerie Hart United Kingdom
Clinical Development Manager, Dermal Laboratories Limited

Nov 24 2022

It was perfect.

Jiwoo Hwang Korea, Republic Of
Student, Dongguk University

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 Denmark
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 Denmark
RA Specialist, Radiometer Medical Aps

May 13 2019

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

Jessica Allen United Kingdom
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 Germany
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 United Kingdom
CRA Lead/ CTM, Cepheid

May 16 2018

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

Karmela Kopcic Croatia
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 Sweden
COO, Glycobond

Nov 14 2018

Great course to give an overview of a very big topic

Louise Corcoran Ireland
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 United Kingdom
Project Manager, Precision for Medicine

May 16 2018

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

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

May 16 2018

Excellent

David Browne Ireland
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 Germany
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 United Kingdom
Managing Director, SGR Consulting Services Ltd

May 16 2018

Very experienced and knowledgable [speakers]. Excellent.

Dawn Chesher United Kingdom
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 United Kingdom
R&D Manager, Sinclair

Nov 29 2017

Effective overview of clinical investigation, quite intensive

Gianluca Colucci United Kingdom
In-House Clinician, Intertek

Nov 29 2017

Very useful course with excellent speakers

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

Nov 29 2017

Knowledgable speakers

Faye Murray United Kingdom
Product Manager Diagnostics, Owen Mumford Ltd

May 9 2017

Excellent, really enjoyed the course.

Jenny Nilsson Sweden
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 United Kingdom
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 Lebanon
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 Sweden
Evidence Strategist, Mölnlycke

Nov 29 2017

Open, knowledgable and clear with good detail

Mina Patel United Kingdom
RA Manager, Medtrade Products Limited

Nov 29 2017

Good overall overview of clinicals

Julie Eyers Ireland
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 Germany
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 United Kingdom
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 United Kingdom
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 Netherlands
Manager Medical Devices, BioTop Medical

Nov 22 2016

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

Phil Rosher United Kingdom
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 United Kingdom
Clinical Research Associate, Biomet UK Healthcare Ltd

United Kingdom