Clinical Evaluation of Medical Devices: The Clinical Evaluation Report In-house Training

I enjoyed the structure and the way the webinar is organized with a very knowledgeable and interesting speaker.

Feb 26 2024

Emina Omeragic
Director Clinical Regulatory Affairs, TRiCares GmbH

Feb 26 2024

I am brand new to the CER world and was hoping to better understand the layout. Janette did a fantastic job helping me to accomplish this. She made it very easy to get a clear picture of the expectations of completing a CER.

Tena Green
Medical Writer/Clinical Consultant, SunMed LLC

Feb 26 2024

It was very organized and beautifully presented

Tena Green
Medical Writer/Clinical Consultant, SunMed, LLC

Feb 26 2024

Very kind and attentive

Nicolas Oviedo
Medical Affairs Specialist, Baxter Healthcare Corp

Feb 26 2024

My goal was to gain an overview on the regulations on medical devices and the general procedure of clinical evaluations. This goal has been achieved.

Hoda Bazafkan
Clinical Evaluations Manager, Geräte GmbH

Feb 26 2024

The training was clear and comprehensive.

Alexandre Jauniaux
Head of division, Federal Agency for Medicines and Health Products

Feb 27 2023

Overall, the webinar was fantastic. Thank you for such solid course.

Remy Serge Manzi-Muhire
Senior Clinical Product Risk Specialist, BOSTON SCIENTIFIC CORPORATION

May 11 2023

Mary-Ann is super nice and professional. She gave a clear presentation and respond to our questions quickly and professionally.

Xue Li
Clinical Regulation Affairs, Geuder AG

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
Senior MD Safety 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