FDA`s Revolutionary Change in Software Regulation 2018 covers topics such as:
- Software no longer under FDA jurisdiction
- 21st Century Cure Act Impact
- Voluntary controls short cuts
- Changes in premarket requirements
- Digital Health Initiative - FDA clearance not required
- Postmarket reporting options
FDA`s Revolutionary Change in Software Regulation 2018 is intended for:
- Production Managers
- Software Designers / Specification Developers
- In-House Legal Counsel
- Quality Assurance Directors