This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with FDA design development regulations and are looking for a place to start in their path towards compliance.
A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process.
Areas Covered in the Session :
Introduction to the DIOM template
Better understanding of FDA regulations with regards to design input and output
How to identify your design inputs
An organized approach in meeting design input and output requirements
How to categorize your design inputs and their sources
Ways in which design inputs can be verified
A simplified way to ensure design inputs and outputs are continually maintained and tracked
Common documents and activities used as design output evidence
Additional requirements of design inputs and outputs
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Regulatory Affairs Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Software Developers and Managers
Internal Auditors
Design Engineers
IT Managers and System Administrators
Software Quality Personnel
Software Test Personnel
Software Validation Engineers