FDA`s Medical Device Software Regulation Strategy is a seminar that covers topics such as:
- Applying FDA classifications / risk controls
- FDA legal authority
- The quality system regulation for risk management, software verification and validation
- FDA and NIST software guidance
- And resolving interoperability issues
- Cybersecurity issues and developing a planned response
- Bug updates classified as recalls by FDA
- The scope of FDAs mobile apps regulation
- Future device software applications
FDA`s Medical Device Software Regulation Strategy brings together:
- Quality Assurance Managers
- Regulatory Affairs Managers
- Manufacturing Managers
- Software Design Engineers
- Hospital Risk Department Personnel
- Compliance Department Personnel
- IT Security Managers
- Software Program Marketers
- Marketing Personnel
