Presented by
Management Forum
Medical Writing for Medical Devices In-house Training
How to produce quality regulatory documents including the clinical evaluation report (CER).
★★★★★ "Janette and Barbara were both great! Very knowledgeable, personable, enthusiastic, friendly, and wit... more (18)"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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. 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.
Benefits of attending
- Learn how to prepare a document that is linguistically and stylistically appropriate
- Understand the effective use of visual elements such as tables, graphs and flow charts
- Examine the content and structure of the CER – an integral part of the submission process
- Be fully aware of what a Notified Body is looking for in your clinical evaluation
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
This 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
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.
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.
Reviews of IPI's Medical Writing for Medical Devices training course
Janette and Barbara were both great! Very knowledgeable, personable, enthusiastic, friendly, and with fantastic presentation skills.
Mar 13 2024
Kiara Batten 
Senior Clinical Trial Manager, Odin Vision
Mar 13 2024
I thoroughly enjoyed the webinar, particularly for its interactive elements. The Q&A sessions, practice opportunities, and Pop quizzes were highlights for me, enhancing the learning experience by encouraging engagement and providing real-time feedback. These interactive parts not only made the content more relatable but also allowed for a deeper understanding of the topics discussed. The presentation was clear and well-structured, and the speakers demonstrated extensive knowledge and passion for their subject matter.
Lloyd Nunag
Clinical Trial Manager, Odin Vision
Mar 13 2024
That is was so interactive - we could always ask and the presenters always has good examples from the real world to illustrate their point. Interaction with the other course participants was also really and useful. It was particularly useful for me to get input to some of the CER content: claims, CDP etc.
Linda Lerdrup 
Clinical Scientific Manager, UNEEG medical
Mar 15 2023
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.
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
Denmark
- Ambu A/S
- Cook Medical
- Demant
- Demant A/S
- Sp Medical
- Thermo Fisher
- Thermo fisher scientific
- UNEEG medical
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
Netherlands
- 3Dsystems
- Dutch Ophthalmic Research Center
- Interdos Pharma BV
- PanPath B.V.
- Vertex-Dental
France
- Becton Dickinson and Company
- Galvanize Therapeutics, Inc.
- Withings Inc
India
- Novo Nordisk Service Centre India Private Ltd
- Novo Nordisk Service Centre India Private Ltd.
- Novonordisk
Switzerland
- Beyond Conception GmbH
- Cochlear AG
- TEOXANE SA
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
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:
