MEDDV 112 - Document Writing for Medical Devices

1. Create coherent text and graphic content for documents used in regulatory-compliant systems.
2. Explain use of regulatory-compliant electronic or hybrid system requirements for technical writing tasks applied to electronic records and electronic signature document approvals.
3. Use FDA and other regulatory agency websites as resources for accessing current compliance information.
4. Collaboratively develop documents using teamwork skills, writing skills, and regulatory-compliant processes.
5. Analyze documentation requirements and respond with the appropriate technical writing solutions and regulatory-compliant processes.
6. Present technical information based on best practices oral-presentations.