Documenting Software for FDA Submissions 2017

Topics

• The role and value of documentation
• Agile vs IEC 62304: an apparent contradiction?
• Specific documents required for an FDA submission
• The REAL regulatory requirements
• Iteration - well suited for risk, usability, and design reviews
• Areas where most development processes bog down
• Agile is not only acceptable for medical device software, but can be clearly superior
• Key practices to bridge the Agile and regulated worlds

Who should Attend

• Quality Assurance Specialists
• Regulatory Specialists
• Test Managers
• Documentation Specialists
• Project and Program Managers
• Software Team Leaders and Lead Developers