Medical Writing for Medical Devices Training Course (March 15-16, 2023)
DUBLIN, Jan 30, 2023 /PRNewswire/ — The “Medical Writing for Medical Devices Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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.
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 fulfill the requirements of the new regulation.
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 program 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.
Who Should Attend:
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Medical device professionals responsible for preparing, writing and completing a CER
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Medical writers producing reports for medical device manufacturers
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Regulatory affairs personnel involved in preparing scientific documentation
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Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products
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Contract research organizations (CROs)
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R&D professionals
Key Topics Covered:
Overview of writing and editing documents
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Substantive and technical aspects
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Considering logic, text flow, wordiness and accuracy
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Looking at the details such as language editing, abbreviations and acronyms
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Preparing a clear message for the intended reader
Regulations applicable to the clinical evaluation of a medical device
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Introduction to the European Medical Device Regulation (MDR)
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Guidance documents for clinical evaluations – what is required?
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Notified Body expectations
Writing regulatory documents
Systematic literature searches for the CER
Aspects of English
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
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Final checks – not just a spell check
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Practicalities, tips and tools
Key take-home messages
Speakers
janette benadi
Director of Clinical & Consulting Europe
NAMSA
barbara grossman
Biochemist
Hawkeye Medical Limited
For more information about this conference visit https://www.researchandmarkets.com/r/w09bh7
Media Contact:
Research and Markets
Laura WoodSenior Manager
[email protected]
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SOURCE Research and Markets