FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018 is a webinar that covers topics such as:
- 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
FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018 is intended for:
- 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