The Role of FDA in Health Care Software Regulations and Development 2015
24 Sep 2015
Webinar
Description
Topics
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?
Who should Attend
Regulatory Affairs Associates
Code Developers working on Medical Applications
QA associates for firms that are developing/revising Medical Software
Health Care Software Marketing Associates
Past Events
The Role of FDA in Health Care Software Regulations and Development 2015 - 24 Sep 2015, Webinar (53375)
Important
Please, check "The Role of FDA in Health Care Software Regulations and Development" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical device, Pharma
Technology: Information Technology (IT), Software & Applications
