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Design Control for Medical Devices: Overview and Design Inputs
- 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
- 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
Overview of the webinar
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.
Who should attend?
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.
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.
Faculty - Mr.Alan M Golden
Alan has over 36 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 26 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 where in 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 management, CAPA, process and test method validation, and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops, and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.