Medical Device Software Verification and Validation

Duration 60 Mins
Level Basic & Intermediate
Webinar ID IQW19J1008

  • Basic Introduction to 62304
  • Level of Concern
  • High Level Risk Management
  • Medical Device Software User Requirements
  • Medical Software Device System Requirements
  • Medical Device Software V Model
  • Software Requirements
  • Software Architecture
  • Software Design
  • SOUP
  • Unit Testing
  • Integration Testing

Overview of the webinar

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Who should attend?

  • Software developers and managers
  • Internal auditors
  • Quality Assurance personnel and management
  • Software quality personnel
  • Software test personnel
  • Regulatory affairs personnel and management
  • IT managers and system administrators
  • Software validation engineers
  • Information Technology Analysts
  • C/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit

Why should you attend?

This webinar is essential for medical device companies interested in submitting software enabled medical devices or software as a medical device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.

This webinar will ensure that device companies will know exactly what documentation needs to be prepared so the software portion of the submittal will be in compliance preventing delays of the 510K approval.

Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk.

Faculty - Ms. Nancy Knettell

Founder and Principle, SoftwareCyber510K, LLC

Nancy Knettell, Founder and Principle of SoftwareCyber510K, LLC has over 30 years in Regulatory, Software Development, and Systems Engineering experience primarily in the Medical Device industry consulting to major Medical Device and IVD companies such as Cook Medical, Johnson and Johnson, ThermoFisher Scientific, Smith and Nephew, and Genomic Health.

Involvement for Nancy, in medical device development, is a personal issue as well. Having lost her father at an early age to heart disease, she now wants to work to help others facing such life threatening events by advancing the potential for life-saving medical devices through the use of quality based software engineering systems.

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