This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a product that is not suited for the intended market or failure of approval to market from regulatory agencies.
WHY SHOULD YOU ATTEND?
This Webinar will outline the basics of design control for medical devices and the device part of a combination product. The webinar will cover the basics of design control and the overall flow of the design control process. It will also cover the aspects of inputs into the design control process (design inputs) and how inputs are key to the entire process. Understanding the process of design control is essential for the successful development of medical devices as well as a regulatory requirement.
AREA COVERED
- Overview of design control
- Need for design controls in device design
- Regulatory requirements
- Design inputs: User Needs
- Design inputs: Product Requirements
- Next steps in design inputs
LEARNING OBJECTIVES
- Understand the need for design control in product development
- Understand the regulatory requirements from both the FDA and CE mark perspectives
- Learn the flow of design control
- Understand user needs, the start of design control
- Understand the translation of user needs to product requirements
- Next steps
WHO WILL BENEFIT?
- Quality professionals
- Regulatory Affairs Professionals
- R&D Scientists
- Production Personnel and Technical Support Personnel.
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