Dublin, April 15, 2026 (GLOBE NEWSWIRE) -- The "Medical Writing for Medical Devices (June 25th - June 26th, 2026)" training has been added to ResearchAndMarkets.com's offering.
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.
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
Key Topics Covered:
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
CPD Hours: 12
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 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.
For more information about this training visit https://www.researchandmarkets.com/r/47luue
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