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Design Control for Medical Devices: Overview and Design Inputs
- 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.
Overview of the webinar
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.
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?
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.
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.