Two Day Seminar: FDA's Medical Device Software Regulation Strategy Lead by Ex-FDA Official (Burlingame, CA, United States - February 16-17, 2017)

Dublin, Jan. 11, 2017 -- Research and Markets has announced the addition of the "FDA's Medical Device Software Regulation Strategy: 2-Day In-Person Seminar by Ex-FDA Official" conference to their offering.

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?

This seminar will focus on addressing these concerns and educating participants on FDA's recent medical device software regulation strategies.

This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA's regulatory radar.

Agenda:

Day One (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

FDA Authority and Regulatory Program

- Types of Software Devices
- Regulatory Strategy
- Risk Classification
- Function and outcome

Medical Device Data Systems (MDDS)
- Office of the National Coordinator (ONC) for Health Information Protection
- Software Regulatory Applications
- FDA Guidance
- Premarket submissions
- Paradigms: aeronautics
- Quality System Regulation (QSR)
- Design verification and validation
- Voluntary standards
- Corrective and prevent action plans
- Voluntary Standards
- Recalls:
- Service / maintenance / recall
- Implementation strategy
- Corrections and Removals Reporting
- Updates: FDA vs. Non-FDA
- Predictive Analytics

Interoperability

- Compatibility by Design
- Hardware
- Software
- Labeling
- Precautions
- Instructions for use
- Use of Voluntary Standards
- Proprietary Information
- Failure Management / Follow Up
- User's vs. Manufacturer's Legal Responsibility
- System configuration
- Customization
- Environment of use
- Professional
- Home use

Day Two (8:30 AM to 4:30 PM)

Cybersecurity

- Device Vulnerabilities: Malfunction and Failure
- Pre-Emption Design
- Latent Malware/Virus
- Post-Event Management
- Corrective action for software
- Disclosure to users
- National Institute of Science and Technology Report

Medical Mobile Applications (Mobile Apps)

- Mobile Apps Defined as a Device
- FDA Regulatory Strategy
- FDA Guidance
- National Institute of Science and Technology Report and Collaboration
- Updates (FDA vs. Non-FDA Updates)
- Criteria for corrective and preventive action deemed recalls
- Reports of corrections and removals
- Reports of adverse events
- Professional vs. Lay Use / Home Use
- Labeling: Instructions for Use and Precautions
- Environment of Use
- FDA Regulation of Accessories
- Federal Communications Commission (FCC) Regulation

For more information about this conference visit http://www.researchandmarkets.com/research/wbhxzz/fdas_medical

CONTACT: Research and Markets
         Laura Wood, Senior Manager
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         Related Topics: Medical Devices