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Faculty: José Mora

  • Date: 9/8/2021 01:00 PM - 9/8/2021 04:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months to find you’re device approval has been denied because the software section of the submittal is inadequate and not compliant is one of the biggest challenges device companies face today. Medical device companies need to join this webinar to ensure that they know exactly what documentation needs to be prepared and submitted. They will also understand how to warrant that all documentation is prepared appropriately so the software portion of the submittal compliant to IEC 62304 regulations. This will ensure delays of the 510K approval are prevented. This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software Life-cycle and software validation protocols. Rather than be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation, it is better to understand what are the practical challenges to the dynamic requirements as devises keep pushing the boundaries of technology and new applications. This will ensure you are not caught off guard by unexpected situations and do not implement requirements haphazardly. Get a complete overview of the imminent changes and their implications, using an innovative approach yet is based upon solid principles and proven practices.

Who Should Attend:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Research and Development Departments
  • Compliance Departments
  • Production Departments
  • Documentation Departments
  • Operations Departments
  • Medical Device Software Engineers
  • Medical Device Software Validation Departments
  • Medical Device Software Compliance Engineers
  • Document Control Teams

Seminar Agenda:

Lecture One:

  • Why is having an IEC62304 Compliant Software Quality System important to both developing your software for 510K approval and how you can be putting your company at risk post-approval if you do not have a compliant system in place
  • What is IEC62304 and how does it differ from other Compliance Standards such as ISO13485
  • What are the elements that constitute an IEC62304 Compliant System?
  • Benefits of developing to an IEC62304 standard
  • What are the components of the Software Lifecycle
  • What are the major Software Work Products developed to the standard?
  • How it fits in with a Company’s Standard Quality Process
  • What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance

Lecture 2:

  • One of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed
  • What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place
  • Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
  • What constitutes compliance with the Standard
  • What areas does the Guidance Address
  • What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance

Lecture 3:

  • Review of Lean Documents and Lean Configuration concepts
  • Software Validation:
    • Software configuration
    • General setup
    • Organization
    • User Management
    • Rights Groups, Roles, and Actors
    • Products
    • Processes
    • Failure Modes, Process Signals, Tasks
    • Screens, menus, and modules
    • Process validation steps
  • Bringing them all together