Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.
Why Should You Attend:
In the development of medical device, incomplete understanding and implementation of design controls will lead to rejection of an application for approval by the FDA or rejection of a CE mark application. Incomplete, vague or conflicting inputs will lead to a product being developed with is not suitable for use and will make it almost impossible to complete appropriate verification and validation of the medical device.
Design Control is fundamental in design and development of medical devices. It is required by the FDA and most regulatory bodies for approval of new medical devices. One of the most fundamental concepts in design control is design inputs, which are the basis of product design and are used to base verification and validation of the device. A good understanding of design control and the basis of initial design inputs is crucial to development of medical devices.
Areas Covered in the Webinar:
- Overview of design control
- Design control flow
- FDA and ISO regulations regarding design control and inputs
- Writing appropriate user needs
- Writing appropriate product requirements
- Design inputs trace
- Documentation and the design history file.
Who Will Benefit:
This webinar is appropriate to anyone working in design, development, marketing or support of regulated medical devices. People working in R&D, Quality Assurance, Validation, Regulatory Affairs, Marketing, Production and Product Support will benefit from this information.
