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


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.

Why You Should Attend:

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.

Areas Covered In The Session:

  • 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

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

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