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.
CPD Hours: 12
Course Content
- Day 1
- Overview of writing and editing documents
- Regulations applicable to the clinical evaluation of a medical device
- Writing regulatory documents
- Systematic literature searches for the CER
- Aspects of English
- Day 2
- Improving readability - be kind to your reader
- Structure and content of the CER
- CER case study workshop
- Introduction to other medical device clinical regulatory documents
- Proofreading essentials
- Key take-home messages
Speakers
Barbara Grossman
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.
Mary-Ann Preston
Mary-Ann Preston has over 30 years’ experience across a broad range of medical device technologies and organisations, from start-ups to multinational companies. She is the founder of her own consultancy, providing medical writing, technical, and strategic regulatory consultancy services to MedTech companies.
Mary-Ann has extensive expertise in the preparation and critical assessment of technical, scientific, and clinical documentation for regulatory submissions, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), PMCF plans and reports, literature reviews, PMS plans and reports, and PSURs. She has supported clients with regulatory strategy, remediation activities, and hands-on development of clinical documentation in line with MDR, IVDR, MEDDEV 2.7/1 Rev 4, MDCG guidance, and related standards.
She has held senior leadership roles within both consultancy and industry, including EMEA Manager for Medical Writing Services at NAMSA and Clinical Practice Manager at RQM+. In these roles, she led teams of medical writers responsible for developing regulatory and clinical evaluation documentation for medical devices and IVDs.
Prior to specialising in regulatory and clinical writing, Mary-Ann spent more than 20 years in medical device R&D, including roles at Smith & Nephew. Her experience spans device design and development, pre-clinical research, biocompatibility testing, and in vivo safety and performance studies supporting regulatory submissions. She has particular expertise in dermal wound healing, sports medicine, and orthopaedics.
Mary-Ann is trained as a biochemist and cell biologist and holds a PhD in dermal wound healing and scarring.
