Management Forum Logo

Presented by
Management Forum

Medical Writing for Medical Devices Training Course

How to produce quality regulatory documents including the clinical evaluation report (CER)

★★★★★ "I learned a lot from this webinar, it was obvious that the speakers (Barbara and Mary-Ann) are not o... more (15)"

1-2 July 2024
+ 21-22 November 2024 »

from £1099

Need help?  Enrol or reserve

Course overview

Writing for medical devices has its own particular skill set and, with important regulatory changes in the industry, all those involved in medical writing face a challenge to ensure they have the necessary expertise and resources to fulfil the requirements of the new regulation.

This comprehensive course has been designed to provide you with a thorough understanding of the essential aspects of medical writing, with a particular focus on medical devices.

Under the guidance of our expert trainers, you will learn how to prepare a document that is linguistically and stylistically appropriate and understand the effective use of visual elements such as tables, graphs and flow charts. The programme will examine the content and structure of the CER – an integral part of the submission process, and ensure that you are fully aware of what a Notified Body is looking for in your clinical evaluation.

Practical exercises and discussion will consolidate learning, and helpful tips and techniques from experts in the field of medical writing and medical devices will enhance your knowledge.

This course is part of our Medical Writing Training Courses series that aims to equip delegates with the tools and techniques needed to thrive within an ever-evolving industry.

Who should attend?

  • Medical device professionals responsible for preparing, writing and completing a CER
  • Medical writers producing reports for medical device manufacturers
  • Regulatory affairs personnel involved in preparing scientific documentation
  • Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products
  • Contract research organisations (CROs)
  • R&D professionals

Enrol or reserve

The Medical Writing for Medical Devices course will cover:

Overview of writing and editing documents

  • Substantive and technical aspects
    • Considering logic, text flow, wordiness and accuracy
    • Looking at the details such as language editing, abbreviations and acronyms
    • Preparing a clear message for the intended reader

Regulations applicable to the clinical evaluation of a medical device

  • Introduction to the European Medical Device Regulation (MDR)
  • Guidance documents for clinical evaluations – what is required?
  • Notified Body expectations

Writing regulatory documents

  • Do different audiences and documents require different approaches?
  • Corresponding with the authorities

Systematic literature searches for the CER

  • Effective search strategies
  • Deciding on what source data is required
  • State of the art

Aspects of English

  • Common errors in English that should be avoided
  • Brief overview of key punctuation points affecting meaning and readability

Improving readability – be kind to your reader

  • Structuring texts
  • In terms of language, how perfect do regulatory documents need to be?

Structure and content of the CER

  • What is required to meet the regulation?
  • Contents of a CER
  • Conducting a clinical evaluation

CER case study workshop

  • Deciding on what source data is needed

Introduction to other medical device clinical regulatory documents

  • PMCF plan and report
  • Clinical investigation plan and report

Proofreading essentials

  • Final checks – not just a spell check
  • Practicalities, tips and tools

Key take-home messages

Enrol or reserve

Barbara Grossman
Hawkeye Medical Limited

Barbara Grossman has a passion for proofreading, quality control, and education. She is a biochemist by training and a medical writer, editor and teacher by profession, with 20+ years’ experience in the pharmaceutical industry. Before starting her own medical writing and consultancy business (Hawkeye Medical Limited), she built up and managed the medical writing group at Covance, the contract research organisation, working in a wide range of therapeutic areas. She has given professional development training at educational institutions and organisations such as the DIA (Drug Information Association – Europe and USA), EMWA (European Medical Writers Association) and NICE (National Institute for Health and Care Excellence), and has led many company-internal training courses.

Barbara is an honorary member of EMWA, was Treasurer 1998–2005, has been an EMWA workshop leader since 2001, served on EMWA’s Education Committee 2010–2018, was the Education Officer for 2 years until 2016, and was EMWA's President for 1 year until May 2020. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.

More details

Janette Benaddi

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

More details

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

1-2 July 2024

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 13777

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 27 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

21-22 November 2024

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 14004

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 17 Oct

View basket 

 
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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Medical Writing for Medical Devices training course


I learned a lot from this webinar, it was obvious that the speakers (Barbara and Mary-Ann) are not only experts in their domains but also passionate about them.

Mar 15 2023

Andrea Parada
Medical Writer, Withings Inc

Mar 15 2023

Barbara Grossman did a wonderful job with her interactive presentations.

Netty Dorrestijn
Clinical Evaluation Officer, Dutch Ophthalmic Research Center

Mar 15 2023

The presenters were great, as were the participants. Very good (funny) examples in the technical writing sections :) Overall very good

Terry Alverson
Sr Director RA/CA, Haemonetics, Inc

Oct 19 2022

Both Janette and Barbara have been great! The course content was very interesting and informative... I really liked how interactive it was - the speakers used polls and several open questions to make the conversation flowing. The workshop was also a great way of exchanging ideas with other participants and put in practice what we had just learnt

Monica Masini
Clinical Expert, GE Healthcare

Oct 19 2022

It was a good summary of all topics.

Melisa Aslan
Clinical Affairs Specialist, KLS Martin L.P

Oct 19 2022

The speakers were really polite and professional

Aliki Kadi
Regulatory Affairs Specialist, Sinclair Pharma Ltd.

Oct 19 2022

Overall was really great.

Angelica Morreno
Regulatory Affairs Assistant, Sinclair Pharmaceuticals

Apr 6 2022

As a non native speaker I wanted to gain experience in writing medical devices study or evaluation reports. I learned alot in which mistakes to avoid and the language to use.

Elona Mulai
Associate Clinical Project Manager, Corcym Srl

Oct 19 2022

Great presentation and the speakers really were experts in the field. Interactive parts were nice (Polls and workshop) gives a better view of why certain topics are thought and keeps you active

Maarten van Veghel
Development Engineer, 3Dsystems

Oct 19 2022

Great presentation and the speakers really were experts in the field... Interactive parts were nice (Polls and workshop) gives a better view of why certain topics are thought and keeps you active

Maarten van Veghel
Development Engineer, 3Dsystems

Oct 19 2022

It was a good webinar, people were encouraged to engage. The presentations were clear and the speakers were good!

Dewi Golsteijn
Laboratory manager, PanPath B.V.

Apr 6 2022

As a non native speaker I wanted to gain experience in writing medical devices study or evaluation reports. I learned alot in which mistakes to avoid and the language to use.

Elona Mulai
Associate Clinical Project Manager, Corcym Srl

Mar 3 2021

The content was really good. A lot was covered. Very experienced presenters, and very knowledgeable.

Isabelle SABOUNTCHI
Senior Consultant, Medical Devices, Beyond Conception GmbH

Mar 3 2021

It is very difficult to make training engaging when performing it remotely but I felt this webinar was really successful from the assistance from Management Forum, to the course content and the interesting speakers. The attendees were really good too as they made the most of the opportunities to participate and ask questions. Overall, I really enjoyed it. Thank you.

Jennine Walker
Clinical Affairs Manager, Dermal Laboratories Ltd

Mar 3 2021

I really enjoyed it! The webinar was well structured, the contents well chosen and Barbara and Janette managed to bring ("teach") their respective contents to us in a simple and effective manner.

Lena Jung
Clinical Affairs Manager, Richard Wolf GmbH

United Kingdom

  • Advanced Healthcare Ltd Unit 2-4
  • Dermal Laboratories Ltd
  • GE Healthcare
  • Hyaltech Ltd
  • LifeArc
  • Odin Vision
  • Red Line Pharmacovigilance
  • Sinclair Pharma
  • Sinclair Pharma Ltd.
  • Sinclair Pharmaceuticals
  • Terumo Aortic

Germany

  • BEGO Implant Systems GmbH & Co. KG
  • Erbe Elektromedizin GmbH
  • Fresenius Medical Care D-GmbH
  • KLS Martin L.P
  • LS medcap
  • Paul Hartmann Ag
  • Richard Wolf GmbH
  • Siemens Healthcare GmbH

Denmark

  • Cook Medical
  • Sp Medical
  • Thermo Fisher
  • Thermo fisher scientific
  • UNEEG medical

Netherlands

  • 3Dsystems
  • Dutch Ophthalmic Research Center
  • PanPath B.V.
  • Vertex-Dental

Switzerland

  • Beyond Conception GmbH
  • Cochlear AG
  • TEOXANE SA

France

  • Becton Dickinson and Company
  • Withings Inc

India

  • Novo Nordisk Service Centre India Private Ltd
  • Novo Nordisk Service Centre India Private Ltd.

Afghanistan

  • Terumo Aortic

Austria

  • Mel-El Elektromedizinische Geraete

Belgium

  • F Care Systems NV

Italy

  • Corcym Srl

Japan

  • Biomedical Solutions Inc.

Singapore

  • ResMed

South Africa

  • Disa Medinotech

United States of America

  • Haemonetics, Inc

Enrol or reserve

Run Medical Writing for Medical Devices Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • 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:

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy