Software Development for Medical Device Applications Under IEC 62304
Duration : 60 Minutes
Don Hurd,
Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, including defense, telecom, aerospace, and medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and Read more
ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. This webinar will walk through the processes outlined in the standard and offer practical advice for implementation.
Course Objectives:
• Establish a baseline understanding of what the standard intends to accomplish
• Discuss the process steps
• Provide an overview of the configuration management aspects
• Describe expectations for postmarket support
• Describe gap closure for legacy software
Why Should You Attend:
Many software developers see the standard, though, as imposing a “waterfall” development methodology; however, this is not the intent; however, a practical application of the standard is not always intuitive. Many feel that the standard enforces a particular methodology, but it can be adopted irrespective of the development methodology. This training session will discuss techniques and methods that have proven successful in regulatory (and test lab) submissions
Course Outline:
• Current state of industry
• Background
• Software Safety Classes
• Development overview
• Software CM
• Maintenance / Postmarket
• Legacy Software
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• software developers
• software development managers
• quality personnel associated with software development projects
• project managers who manage projects with a software development component
• management (for understanding resource requirements)
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
