FDA`s Medical Device Software Regulation Strategy is a seminar that covers topics such as:
- Understanding FDA legal authority
- Applying FDA classifications / risk controls
- Understanding FDA and NIST software guidance
- Identifying the quality system regulation for risk management, software verification and validation
- Identifying cybersecurity issues and developing a planned response
- Identifying and resolving interoperability issues
- Figuring out the scope of FDA’s mobile apps regulation
- Learning about bug updates classified as recalls by FDA
- 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