Duration: 60 Minutes


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Design planning, use and maintenance of design history files and periodic design reviews are crucial and integral parts of design control.  All development projects in the medical device space will start with design planning. Without robust planning, it is not possible to keep track of everything that is needed during the development of a medical device. The planning stage and process will lay out and define the tasks needed to complete the development process as well as define subordinate plans to keep track of related activities such as regulatory or production plans.  Proper use and application of the design history file is not only required but essential in documenting the development process. All records related to the development of a product are stored in the design history file and as such, it must be organized, accessible, searchable and secure.   Finally, design reviews are key to track the progress of a design project and a way for management to be formally updated as to where the project stands in relation to goals and what management can do to help if there are delays or setbacks. Design reviews also serve to allow management to approve at key milestones and final product release.

Why You Should Attend:

This webinar delves into the critical aspects of designing medical devices, emphasizing meticulous planning, comprehensive documentation, and rigorous review processes. Participants will gain insights into the regulatory requirements, best practices, and strategies essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. The session will explore the significance of Design History Files (DHF) as comprehensive records of the design process, covering design inputs, outputs, verification, validation, and changes. Additionally, it will highlight the pivotal role of design reviews in identifying potential issues, assessing risks, and enhancing the overall design process. By addressing key challenges and providing practical guidance, this webinar equips participants with the knowledge and tools necessary to navigate the complex landscape of medical device design effectively.

Attending this webinar is crucial for professionals involved in the medical device industry to stay abreast of regulatory requirements and industry best practices. By participating, you will gain valuable insights into the intricacies of medical device design planning, DHF management, and design review processes. This knowledge is indispensable for ensuring compliance, mitigating risks, and delivering safe and effective medical devices to the market. Whether you are a regulatory affairs specialist, design engineer, quality assurance professional, or involved in product development, this webinar provides a comprehensive understanding of the essential elements required for successful medical device design and regulatory submissions. Join us to enhance your skills, streamline your processes, and contribute to the advancement of healthcare technology.

Learning Objectives:

  • Regulatory requirements for medical device design planning
  • Importance and components of Design History Files (DHF)
  • Documentation strategies for design inputs, outputs, verification, and validation
  • Change control and management in the design process
  • Role and significance of design reviews in ensuring product quality and safety
  • Risk assessment methodologies in medical device design
  • Best practices for conducting effective design reviews
  • Case studies and examples illustrating key concepts and challenges

Areas Covered in the Session :

  • Quick review of design control flow
  • Design planning
    • What is it?
    • Why do it?
    • Aspects
  • Design History File
    • What is it?
    • Structure
    • Systems
    • Use
  • Design Reviews
    • Why
    • What
    • How many
    • Who

Who Should Attend:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Product Development Professionals
  • Design Engineers
  • Compliance Departments
  • Clinical Affairs Professionals

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.

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