Presented by
Management Forum
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
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
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
Until 09 Oct
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.
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
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2 days
Typical duration
Pricing from:
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:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: