FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018
12 Oct 2018
Webinar
Description
Topics
Software Application changes for software used in conjunction with medical devices
Medical Device changes
FDA Enforcement
FDA Guidance Documents
Flowcharts for decision-making related to specific changes:
New 510(k) submission
Technology, Engineering and Performance
Labeling
Q&A
Materials
Who should Attend
IT Developers
Information Technology (IT) Analysts
QC/QA Managers and Analysts
IT Support Staff
Analytical Chemists
Clinical Data Managers and Scientists
Compliance Managers and Auditors
Quality Managers, Chemists and Microbiologists
Automation Analysts
Lab Managers and Analysts
GMP Training Specialists
Computer System Validation Specialists
Regulatory Affairs Personnel
Business Stakeholders using Computer Systems regulated by FDA
Interns working at the companies listed above
Consultants in the Life Sciences and Tobacco Industries
Past Events
FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018 - 12 Oct 2018, Webinar (70246)
Important
Please, check "FDA`s New Draft Guidance on Software and Device Changes and the 510(k)" official website for possible changes, before making any traveling arrangements
