🎤  Alan M Golden       |  📅  Recording Available   |  🕒  60 Minutes


Description:

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


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