2020 - Medical Device Industry Trends for Computer Systems Regulated by FDA

Computer System Validation (CSV)
System Development Life Cycle (SDLC) Methodology
“GxP” – Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Retention/Archival to ensure security, integrity and compliance
Validation Strategy/Planning that will take into account the system risk assessment and system categorization (GAMP V) processes
Software used as a component of a medical device
Software as a medical device (SaaMD)
Policies and Procedures
Critical Training and Organizational Change Management (OCM)
FDA Regulatory Trends
FDA Response to Change
Recent FDA findings for companies in regulated industries
Recent trends in technology that need to be addressed in the CSV approach
Industry Best Practices
Q&A