Good Documentation and Writing Practices for Regulatory Submissions

September 22, 2011 | BY Georgiann Keyport

This excellently documented 60 minute course will provide you with the necessary steps in preparing a regulatory submission for a medical device in the United States. The overview of the process steps include:

• Regulatory Submission Basics
• Submission Planning
• Submission Writing
• Supporting Documents and Data
• Lifecycle Management version

 

  See full course description here