Overview:
In this webinar, we will examine the overall structure of design control as it relates to the development of medical devices.
Emphasis will be placed on design control flow and how aspects of design control work together. Additional areas of emphasis will be on the importance of design inputs, as well as design verification and design validation. Design outputs, and the design history file will also be discussed.
Why you should Attend:
The concepts and implementation of design controls is required for development and manufacture of medical devices and combination products where one or more components(s) is a medical device. Failure to properly implement design control in development, manufacture can result in products not being approved for sale or removed from market. Failure to introduce and implement design controls can also result in the development of the wrong product or the right product for the wrong market.
Areas Covered in the Session:
- Overview of Design Control for Medical Devices
- Overview of design inputs (requirements)
- Regulatory aspects
- A look at Design Inputs
- Where do they come from
- Flow
- Traceability
- Design Verification
- Design Validation
Who Will Benefit:
- Quality Assurance Professionals
- R&D Scientists
- Development Scientists and Engineers
- Manufacturing Personnel and Development Engineers
- Regulatory Professionals