Medical Writing for Medical Devices

Key Topics

• Regulations applicable to the clinical evaluation of a medical device
• Overview of writing and editing documents
• Systematic literature searches for the CER
• Writing regulatory documents
• Improving readability – be kind to your reader
• Aspects of English
• CER case study workshop
• Structure and content of the CER
• Proofreading essentials
• Introduction to other medical device clinical regulatory documents
• Key take-home messages

Who should Attend

• Medical writers producing reports for medical device manufacturers
• Medical device professionals responsible for preparing, writing and completing a CER
• Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products
• Regulatory affairs personnel involved in preparing scientific documentation
• R&D professionals
• Contract research organisations (CROs)