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.
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.
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.
Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.Alan’s quality assurance experience extends from design control, change control, risk …
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