The Role of FDA in Health Care Software Regulations and Development 2015 is a webinar that covers topics such as:
- How to tell if the software you are developing is a medical device
- Who regulates software and why
- What are the expectations for software that’s an integral part of a device
- What does "enforcement discretion" mean and how does it apply to software
- What about software used in the manufacturing process but not sold
- What about software that is offered to analyze signal from a medical device, but is not a part of the device, has a different manufacturer and seller? (e.g., sequencer raw data from manufacturer A, can be analyzed by software from either software seller B or C, and translated using different interfaces from either B or C to the local LIMS
- And what does Part 11 have to do with my software?
- Who is enforcing HIPAA, Patient privacy, for device software?
The Role of FDA in Health Care Software Regulations and Development 2015 is intended for:
- Regulatory Affairs Associates
- Code Developers working on Medical Applications
- QA associates for firms that are developing/revising Medical Software
- Health Care Software Marketing Associates
