Presented by
Management Forum
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
★★★★★ "Overall, the webinar was fantastic. Thank you for such solid course."
11-12 May 2023
+ 2 more dates
This two-day introductory course will cover all aspects of clinical evaluation in line with the European Medical Device Regulation (MDR) and applicable guidance documents. The programme will provide you with the tools and skills you will need to produce a high-quality clinical evaluation report (CER) for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a CER that is acceptable to the regulatory authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post-market aspects of clinical evidence.
The programme includes case studies and template documents which you will be able to utilise to produce your own clinical data evidence documentation.
Benefits of attending:
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
11-12 May 2023
Live online
09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Course code 12136
Until 06 Apr
Not ready to book yet?
for 7 days, no obligation
7-8 August 2023
Classroom
Rembrandt Hotel
London
09:00-17:00 UK (London)
Course code 12286
Optional £275/€395/$450 per night
Until 03 Jul
Not ready to book yet?
for 7 days, no obligation
29-30 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 12443
Until 25 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.
Overall, the webinar was fantastic. Thank you for such solid course.
Feb 27 2023
Remy Serge Manzi-Muhire
Senior Clinical Product Risk Specialist, BOSTON SCIENTIFIC CORPORATION
Nov 28 2022
I wanted to obtain solid base knowledge on how to conduct clinical evaluation activities. The purpose was achieved.
Natalia Kostiukhina
Clinical Evaluations Manager, MED-EL Medical Electronics
Nov 28 2022
I really enjoyed the webinar. Since I am at the very beginning of my experience with CERs, I appreciated the nice overview on all topics concerning a CER and related documents. Presentations were really clear and well-structured and Janette was really nice and available for any additional explanations.
Barbara Fogli
Clinical Evaluations Manager, MED-EL Elektromedizinische Geräte GmbH
Aug 8 2022
I was very impressed with the course and came out of it feeling much more confident in my ability to write a CER. I found Janette particularly engaging and inspiring to listen to, as a newcomer to the medical devices industry.
Kate Ward
Clinical Affairs Specialist, Rocket Medical Ltd
Aug 8 2022
It was informative and I am much more confident in writing a clinical evaluation file. The brainstorming sessions were excellent.
Pavankumar Kalla
Regulatory Specialist, TNI medical Ag
Dec 1 2021
The presenter was pleasant, knowledgeable and helpful. The participants all contributed a lot and there was good interaction. The presentation was well-paced.
Fiona Broderick
Senior Medical Writer, Norgine
Jun 8 2021
I thought this was a terrific webinar, lead by an excellent topic expert, and I feel much more confident about participating and/or leading the CER update at my company.
Juliana Pugmire
Clinical Research Consultant, Current Health
Jun 8 2021
Janette is very nice and friendly. She has a lot of relevant knowledge and experience about the clinical evaluation process and the report. I learned a lot form her!
Dror Sever
Senior Device Information Scientist, Novo Nordisk
Dec 1 2021
Janette is a very engaged speaker - I really enjoyed having her as my course instructor.
Matilde Kveiborg
Larix A/S
Dec 1 2021
this was a very good brush up of the Clinical Evaluation of Medical Devices
Line Kynemund Pedersen
PV Physician , Ferring Pharmaceuticals A/S
Jun 8 2021
It was overall a very good webinar that gave a nice overview of the Clinical Evaluation proces. A shame it had to be a webinar due to the Covid-19 situation, it would have worked better if we could all meet in person and also have small conversations in breaks and so on.
Christina Frary
research audiologist, Demant
Dec 1 2020
Everything was perfect.
Amnah AlKhan
Regulatory Affairs Specialist, Gulf Health Council
Nov 26 2019
Everything perfect!
Katarzyna Paluszynska
Clinical Associate, EduBroker Sp.zo.o
Nov 26 2019
Janette is excellent. Her knowledge and ability to clearly communicate in an engaging way about the topic at hand really mean that it's very easy to learn and understand what is being discussed. The workshops were very useful in cementing what you've learnt and also bouncing ideas around. Absolutely excellent, fantastic speaker, wealth of knowledge, discussion welcomed!
Alex Hyde
Senior Regulatory Affairs Specialist , Sinclair Pharma
Nov 26 2019
Wonderful speaker, friendly and approachable. He manages to put a lot of information over in a short period, in a simple way, making it a lot easier to digest. Overall, an amazing teacher and incredibly knowledgeable in regulations concerning medical devices. I particularly liked the interaction and encouragement of the group activities and communication. An amazing course, well structured, and a knowledgeable, friendly and approachable speaker.
Hannah Vince-Drew
Clinical Research Supervisor , Bedfont Scientific
Jun 5 2019
Communication very clear. Immense knowledge and experience. Entertaining. Very open re. questions. Made everybody feel well and acknowledged. Able to create team spirit. Structured. Kept time. Good flow. Fantastic overview with an eye on the details. What's not to like :)
Lise Bruun Hansen
Lead Clinical Audiologist, Demant a/s
Jun 5 2019
Very good teacher. No doubt that she knows what she is talking about and I got more out of the training than I had hoped for. I really liked that we were so few people attending the training, so there was plenty of time to asking questions and discuss the topics.
Karen Elise Karlsmose Boel
Head of Clinical Audology and Usability, Demant a/s
Jun 5 2019
Janette was both very proficient regarding CE both also a lively and engaging presenter. It was a very good course, both content and duration was great
Per Videbæk
Team Manager Clinical Audiology, Demant a/s
Nov 26 2019
The speaker was very knowledgeable, able to answer all questions and allowed time for discussion of everyone's experiences. I learnt a lot and feel it was definitely worth the time.
Alice Sugden
Clinical Trials Submissions, AbbVie
Nov 26 2019
The content is quite comprehensive, the presentation is clear and the speaker is very experienced. Both newbies and experienced people can benefit from this course, especially at the time of MDR transition.
Huajie Bu
Clinical Evaluations Manager, MED-EL Elektromedizinische Geräte GmbH
Dec 6 2018
Very efficient course, explanations were clear in a rather unclear (!) topic, interaction between speaker and attendees promoted the exchange of experiences and opinions. The speaker was well-informed, conveyed the information efficiently. There was a team spirit in dissecting the different aspects of the course's subject. A successful two-day seminar worth of attending.
Athanassios Vratimos
International Product Manager, Rontis AG
Dec 6 2018
Expected content, clear presentation, very approachable speaker
Teresa Lopes
Manager Medical Devices, BioTop Medical
Dec 6 2018
Janette was very patient and professional. She allowed the group to share ideas and engage with each other well. I thought she recognised that on this particular occasion the group engagement was positive and she adapted the course to accommodate interactive discussion. Highly recommend this one.
Shirley-Ann van der Spuy
Managing Director & EU QPPV, Red Line Pharmacovigilance 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: