510(k) Documentation Best Practices for Software or Software Enabled Medical Devices 2018

510(k) Documentation Best Practices for Software or Software Enabled Medical Devices 2018 is an event dedicated to "Learn the key elements and best practices of 510K documentation for software.

Topics

• What specific documentation is required for Class B Medical Device Software for submittal?
• Why is Compliance to IEC62304 essential to preparing software documentation to submit successfully to the FDA for a 510K/
• The Key Guidance that the FDA is expecting to be followed within the Software Development and Verification/Validation Process.
• What Constitutes Compliance
• Setting up Design Development Documentation correctly to ensure compliance to the standard.
• What documentation is required to support different Classes of Medical Device Software
• What are the serious legal risks to the Company in not ensuring Compliance with Post Market audits?

Who should Attend

• Medical Device Software Quality Assurance Engineers
• Medical Device Software Regulatory professionals
• Medical Device Software Company Senior Management
• Medical Device Software Quality Senior Management
• Medical Device Quality Senior Management
• Medical Device Quality Engineers
• Medical Device Software developers
• Medical Device IT
• Software validation engineers
• Medical Device Management
• Product Development managers
• Manufacturers of medical devices
• Project managers and documentation specialists
• Regulatory managers
• Medical device IT specialists
• Medical writers
• Medical device and 510(k) consultant