Healthcare Medical Software/Applications - Risks, Validation & Interoperability 2017

Topics

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

Who should Attend

• Senior Managers of Manufacturing Operations
• Medical Device Software Design Engineers
• Managers for software based medical devices
• Regulatory Affairs Auditors
• Sales and Marketing
• Risk Managers
• Institutional and Clinical Software Users
• Software Vendors
• Cyber Security Manager