Software Regulations 2016 - Conference about The Role of FDA in Health Care Software Regulations and Development

Overview:
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device
Why should you Attend:
Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance).
Also, with the proliferation of numerous applications in the Health Care, some developers are still unsure whether or not their product is a medical device. Finally, even though some applications can meet the definition of a medical device, Guidance indicates that FDA is not going to regulate them. Can you tell which is which?
Areas Covered in the Session:
Who regulates software and why
How to tell if the software you are developing is a medical device
What does “enforcement discretion” mean and how does it apply to software
What are the expectations for software that’s an integral part of a device
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
What about software used in the manufacturing process but not sold
Who is enforcing HIPAA, Patient privacy, for device software?
And what does Part 11 have to do with my software?
Who Will Benefit:
Code Developers working on Medical Applications
Regulatory Affairs Associates
Health Care Software Marketing Associates
QA associates for firms that are developing/revising Medical Software
Speaker Profile:
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Health_Care_Software
LinkedIn Like us ? https://www.linkedin.com/company/compliance4all
Twitter Follow us ? https://twitter.com/compliance4all
Facebook Like us ? https://www.facebook.com/Compliance4all