Duration: 60 Minutes


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This webinar to delve into the fundamental principles of design control for medical devices and the device components of combination products. Neglecting design control can jeopardize your product's suitability for its target market and hinder regulatory approval. Unveil the intricate art of design control, and master the entire design control process. Gain profound insights into the pivotal role of design inputs, the driving force behind a successful product development journey. Understanding the design control process is not just a choice; it's a regulatory imperative. Embark on a journey towards crafting exceptional medical devices that meet the highest standards.

Learning Objectives:

  • 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

Areas Covered in the Session :

  • Overview of design control
  • 21 CFR Part 820 Subpart C - Requirements
  • Need for design controls in device design
  • Regulatory requirements
  • Design inputs: User Needs
  • Design inputs: Product Requirements
  • Next steps in design inputs

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Scientists

Course Director: ALAN M. GOLDEN

Alan has over 30 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 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 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.