Medical devices, and the device part of a combination product, must be developed under design control. Without it, you risk a product that does not suit its intended market or that regulators will not approve.
This 60-minute medical device design control training explains the basics and the overall flow of the design control process, including the regulatory requirements from both the FDA and CE mark perspectives.
The session focuses on design inputs, the foundation of the process: starting with user needs, translating them into product requirements, and the next steps that follow.
Understanding design control is both a regulatory requirement and a key to developing devices successfully. Getting design inputs right shapes everything that follows in development.
This session suits quality and regulatory affairs professionals, R&D scientists, and production and technical support staff working on medical devices or combination products.
Understanding design control is both a regulatory requirement and a key to developing devices successfully. Getting design inputs right shapes everything that follows in development.
This session suits quality and regulatory affairs professionals, R&D scientists, and production and technical support staff working on medical devices or combination products.
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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