OVERVIEW

3 hours virtual seminar on: Healthcare Medical Software/Applications - Risks, Validation & Interoperability is organized by Online Compliance Panel and would be held on Jun 06, 2017.

By attending this training attendees will learn how to navigate the world of the regulatory realities. Attendees will participate in an interactive learning experience in terms of software regulation and what appears to be on the horizon. Attendees will learn how to understand their direct or indirect software based products in terms of current regulatory requirements and policy. Attendees will be equipped to develop an informed regulatory strategy.

Areas Covered:
• Current regulatory approaches
• Risk based classification
• Proposed regulation and guidance
• Future regulatory strategy
• Impact of regulation
• Premarket requirements
• Post market requirements
• Marketing boundaries
• Regulatory action
• Enforcement action
• Quality Systems regulation
• Design and validation
• Corrective and preventive actions
• Required regulatory reporting
• Medical Device Data Systems (MDDS)
• Regulatory scope
• Device classification criteria
• Implementation issues
• Industry issues
• Interoperability issues
• Device interface
• Servicing
• Professional and consumer use
• Mobile Applications

Conference Objectives are :
• Understand the regulatory landscape
• Identify software regulation criteria
• Reconcile the impact of software regulation
• Learn to manage software's risk to health
• Learn Quality Systems manufacturing requirements
•Understand initiatives for regulating mobile applications