Medical Writing for Medical Devices Training Course

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.

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

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