Technical Writing for Medical Devices

This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing their audience, in effect producing effective written correspondence.

• Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• Know how the reporting process supports products in the medical device industry.
• Understand how documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final report
• Know how to produce effective written correspondence
• Understand how to assess and write to the audience
• Know how to organize and deliver information based on the message
• Understand how to structure reports
• Understand the innate structures of English grammar
• Know how to create grammatically sound passages
• Understand how the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
• Have a working knowledge of punctuation marks and their role in making documents readable
• Know how to review and revise documents
• Understand your own writing patterns and know the answers to your questions about the English language
• Have increased confidence in writing and revising documents

This course will address how to write effective correspondence and reports in support of medical device manufacturing activities. Attendees will learn how to organize and deliver information to the intended audience. They will also learn how to write clear and readable documents, and how to revise and refine their own and others’ writing.

The course will provide an overview of sound grammatical conventions, address problematic areas of the English language, and afford opportunities to address specific language issues.

• Medical Device Manufacturers
• Quality Assurance Departments in the Medical Device Industry
• Information Technology Departments in the Medical Industry
• Medical Device Operations
• Medical Device Production Departments
• Medical Device Documentation Departments