Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each

Date	Jul 31, 2018
Time	03:00 PM EDT
Cost	$16104.00
Online

After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became effective, many warning letters has been issued for failures to fully implement the controlling regulations.

Areas Covered in the Session :

• The Design History File (DHF)
• The Device History Record (DHR)
• The Device Master Record (DMR)
• Change Controls
• Impact of Change Controls on each
• Documentation associated with each

Who Should Attend:

• Research and Development Departments
• QA/QC Departments
• Regulatory Affairs Departments
• Quality Management Teams
• Documentation Departments
• Combination Products Design Personnel
• Production Teams
• Marketing Teams