Design Control for Medical Devices and Combination Products

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.

• Explain why design control is needed in product development
• Describe FDA and CE mark design control requirements
• Follow the overall flow of design control
• Identify user needs as the starting point of design control
• Translate user needs into product requirements
• Plan the next steps after design inputs

• Overview of design control
• Why device design needs design controls
• Regulatory requirements from the FDA and CE mark perspectives
• The flow of the design control process
• Design inputs: user needs
• Design inputs: product requirements
• Next steps after design inputs

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.

• Quality professionals
• Regulatory Affairs Professionals
• R&D Scientists
• Production Personnel and Technical Support Personnel.

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 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.