FDA Perspective - Featured Speaker

  • Ron Kaye
    Human Factors, Pre-Market Evaluation Team Leader
    FDA

Benchmark your methods against leading innovators:

Investigating Software Design Solutions, Demonstrating Cause & Effect and Demystifying Compliance

Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software innovation are balanced by the risk and challenges of regulation, stringent quality requirements, market pressures, and significant complexity. Balancing these competing interests requires tailored application lifecycle management that addresses the unique needs of medical device companies. Attend the 15th Annual Software Design for Medical Devices to learn how to:

  • Handle issues of interoperability
  • Integrate Human Factors considerations
  • Establish high repeatability
  • Apply risk management standards to device software
  • Investigate Agile methods for documentation
  • Understand new FDA guidance and how to pass an audit
  • Acquire a set of QA automation tools

Who you will meet?

Chiefs, VP’s, Directors, Heads, Senior Directors and Managers of:

  • Software Engineering
  • Product Development
  • Research and Development
  • Quality Assurance
  • Regulatory Affairs
  • Risk Management

Testimonials:

“Excellent- Can’t wait to take this back to my organization”
Software Engineering Manger, IU- Cyclotron Operations
“Focused, practical & knowledgeable presentation”
VP R&D, CareFusion
“Content was on point”
Director of Technology and Development, Applied Medical
“Good emphasis with examples, to “drive home” the message”
Associate SW Engineer, Medtronic CryoCath LLC
Sponsors Media Partner
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[ Register Now ]