Presented by
Management Forum
Medical Device Studies: Clinical Evidence Training Course
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
★★★★★ "Janette is a very good speaker; she is very prepared and provided lots of contents and information d... more"
12-13 July 2023
+ 13-14 November 2023
from £1099
- Format: Live online
- 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
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 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
Mary-Ann Preston
NAMSA
Mary-Ann Preston is the EMEA manager for medical writing services at NAMSA, a medical research organization providing full-service support throughout the product development process for medical devices, diagnostics, and combination products.
Mary-Ann is responsible for a team of medical writers who prepare clinical evaluation reports (CER), performance evaluation reports (PER), and other documents in accordance with regulatory requirements (e.g. Medical Device Regulation and In vitro Diagnostic Regulation), various guidance (e.g. MEDDEV 2.7/1 revision 4 and medical device coordination group documents) as well as other applicable documents and standards. She has extensive experience in the critical assessment and interpretation of technical, scientific, and clinical data for CERs, PERs, literature reviews, scientific reports, and regulatory submissions. Utilizing her strong background within the medical devices industry, Mary-Ann has provided regulatory consultation, remediation, and hands-on assistance to clients on all aspects of PERs and CERs.
As well as clinical expertise, Mary-Ann has over 20 years of R&D experience in medical devices. Her background includes the design, development, and management of pre-clinical research for medical devices from scoping, and proof of concept stage through to pivotal development, biocompatibility testing, and in vivo safety and performance studies for regulatory submissions. She has developed medical device expertise in the therapeutic areas of dermal wound healing, sports medicine, and orthopaedics.
Mary-Ann is a biochemist and cell biologist by training, with a Ph.D. in dermal wound healing and scarring.
Before joining NAMSA, she held various senior roles at another consultancy and a leading manufacturing company, Smith & Nephew.
Book Medical Device Studies: Clinical Evidence Live online training
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
12-13 July 2023
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 12291
- GBP 1,299
- EUR 1,869
- USD 2,129
- 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
Not ready to book yet?
for 7 days, no obligation
13-14 November 2023
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 12416
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 09 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
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.
Reviews of IPI's Medical Device Studies: Clinical Evidence training course
Janette is a very good speaker; she is very prepared and provided lots of contents and information during these 2 days.
Nov 24 2022
Giulia Carli 
Global Clinical Affairs Programme Manager, Corin Ltd
Nov 24 2022
Good knowledge and information provided
Valerie Hart
Clinical Development Manager, Dermal Laboratories Limited
Nov 24 2022
It was perfect.
Jiwoo Hwang 
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 
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
United Kingdom
- Allergan
- Allergan UK Limited
- BBI Solutions
- Bedfont Scientific
- Biogen Idec Ltd
- Biomet UK Healthcare Ltd
- Cepheid
- Cerapedics Inc.
- Corin Ltd
- CROMSOURCE
- DePuy Synthes
- Dermal Laboratories Limited
- 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
Germany
- BSN medical GmbH / Essity
- Definiens AG
- Grunenthal GmbH
- Kulzer
- Merz Pharmaceuticals GmbH
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
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.
Korea, Republic Of
- Dongguk University
Lebanon
- Benta SAL
Saudi Arabia
- Saudi Food and Drug Authority
United States of America
- USGI Medical
Run Medical Device Studies: Clinical Evidence Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
