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FDA's Medical Device Software Regulation Strategy

FDA's Medical Device Software Regulation Strategy

Views: 576

06/09/2016 - 06/10/2016

Venue TBD

San Francisco, CA 94108

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Add to Your Calendar 06-09-2016 00:00:00 06-10-2016 00:00:00 11 FDA's Medical Device Software Regulation Strategy The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?Can one software program defeat the performance capability or back up safety features of another software program?When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues? Learning Objectives:Understanding FDA legal authorityApplying FDA classifications / risk controlsUnderstanding FDA and NIST software guidanceIdentifying the quality system regulation for risk management, software verification and validationIdentifying cybersecurity issues and developing a planned response Who Will Benefit:Regulatory Affairs ManagersQuality Assurance ManagersSoftware Design EngineersManufacturing ManagersCompliance Department PersonnelHospital Risk Department Personnel Note:Use coupon code NB5SQH8N and get 10% off on registration... Venue TBD ComplianceOnline true MM/DD/YYYY

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The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
Can one software program defeat the performance capability or back up safety features of another software program?
When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

Learning Objectives:
Understanding FDA legal authority
Applying FDA classifications / risk controls
Understanding FDA and NIST software guidance
Identifying the quality system regulation for risk management, software verification and validation
Identifying cybersecurity issues and developing a planned response

Who Will Benefit:
Regulatory Affairs Managers
Quality Assurance Managers
Software Design Engineers
Manufacturing Managers
Compliance Department Personnel
Hospital Risk Department Personnel

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:
http://www.complianceonline.com/fda-medical-device-software-regulation-strategy-seminar-training-by-ex-fda-official-seminar-training-80242SEM-prdsm?channel=eventsinamerica

There may be many networking opportunities at the FDA's Medical Device Software Regulation Strategy. Find out more in the event details below.

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Website: http://www.complianceonline.com/fda-medical-device-software-regulation...
Conference/Event Dates: 06/09/2016 - 06/10/2016
Conference/Event Hours: 8:30 AM - 4:30 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Sciences, Software, Technology
Estimated Attendance: 30
Cost to Attend: One Registration - $1599
Audience: Regulatory Affairs Managers
Quality Assurance Managers
Software Design Engineers
Manufacturing Managers
Compliance Department Personnel
Hospital Risk Department Personnel
Venue: Venue TBD
Show Owner:ComplianceOnline

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FDA's Medical Device Software Regulation Strategy

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