Medical Device Software 2016 - Conference on Medical Device Software Tougher Regulation

Course "FDA's Tougher Regulation of Medical Device Software" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Software pervades our lives. Likewise, the risks and vulnerabilities of software sneak into our lives. The use of software in medical devices or as a stand-alone product outpaces the FDA's ability to keep up with the technology and its uses. Software applications develop like a fountain of possibilities and leeks. There are no perfect software applications. The FDA's regulatory approach has become increasingly stringent in terms of what software developers must consider, design about and validate. Successful use requires risk analysis, particularly for factors that are really beyond the control of the software program developer and user. Using software in blind faith leads to serious trouble. Medical device software faces daily failures due to the lack of interoperability, communication technology, cybersecurity and firms' inadequate attempt to correct of prevent problems. One current example involves holding medical centers' software hostage until a ransom is paid. The Department of Justice estimates that 4000 ransom attaches happen each day. The FDA has stepped up its level of regulatory control of software on the premarket and postmarket market side. The Office of the National Coordinator for the federal government's use of software for healthcare applications is using a peculiar approach that affects what the FDA does. Software vulnerabilities and associated healthcare risks have a stronghold on patient care and lay use. The industry and the FDA find itself in a race to catch up with it.
For decades, software has been a leading cause for recalls, deaths and serious injuries. The FBI has stated publicly that the healthcare industry and the FDA are the least prepared commercial entities to respond to intentional software corruption. Hospitals' computer systems are routinely hacked, closed down and held ransom. Hackers can shut down a software based device from a remote location or plant malware that makes patient information public. Manufacturers also create risks amongst themselves because their products are not inter-operable. Almost all hospitals have experienced this problem to one degree or another. Why would a firm buy your product when it is not compatible with other products it already uses? The federal government has forged new inroads into the problem. Firms must keep pace with the FDA's demand for software information and design requirements. Likewise, firms must learn how to apply Quality System regulation requirements and the Total Product Life Cycle paradigm used by the FDA. Beyond the FDA, you need to know and follow that evolution of current technology and applicable guidance. The National Institute of Standards and Technology is particularly important in this regard.
Learning Objective:
FDA's regulatory strategy
Pre-market and post-market controls
? Total Product Life Cycle
o Recalls
o Adverse events
? Voluntary standards
? National Institute of Science and Technology
? Interoperability
? Cybersecurity
? Mobile Apps
? Professional Use and Home Use
Who Will Benefit:
? Regulatory Affairs
? Quality Assurance
? Software Design Engineers and Programmers
? Manufacturing
? Medical Facility Risk Managers
? Enterprise Software Users
Agenda:
Day 1 Schedule:
Lecture 1:
FDA regulatory strategy
? Types of Software devices
? Regulatory strategy
? Risk classification
o Function and outcome
? Medical Device Data Systems (MDDS)
? Office of the National Coordinator (ONC) for Health Information Protection
? Software regulatory applications
? FDA Guidance
o Premarket submissions
o Paradigms: aeronautics
? Quality System Regulation (QSR)
o Design verification and validation
o Voluntary standards
o Corrective and Prevent Action Plans
? Voluntary standards
? Recalls:
o Service / maintenance / recall.
o Implementation strategy
? Corrections and Removals reporting
? Updates: FDA vs. non-FDA
? Predictive analytics
Lecture 2:
Interoperability
? Compatibility by design
o Hardware
o Software
? Labeling
o Precautions
o Instructions for use
? Use of Voluntary Standards
? Proprietary information
? Failure management / follow up
? User's vs. manufacturer's legal responsibility
o System configuration
o Customization
o Environment of use
? Professional
? Home Use
Day 2 Schedule:
Lecture 1:
Cybersecurity
? Device vulnerabilities: malfunction and failure
? Pre-emption design
? Latent malware/virus
? Post-event management
o Corrective action for software
o Disclosure to users
? National Institute of Science and Technology Report
Lecture 2:
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)
o Criteria for corrective and preventive action deemed recalls
o Reports of Corrections and Removals
o Reports of adverse events
Lecture 3:
Professional vs. lay use / home use
? Labeling: Instructions for use and precautions
? Environment of use
? FDA Regulation of accessories
? Federal Communications Commission (FCC) regulation
Speaker:
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH
Casper (Cap) Uldriks , through his firm Encore Insight LLC, brings over 32 years of experience from the FDA. He specialized in the FDAs medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.
He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDAs domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Location: Chicago, IL Date: October 20th & 21st, 2016 Time: 8:30 AM to 4:30 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,295.00 (Seminar fee for One Delegate)
Until September 20, Early Bird Price: $1,295.00 From September 21 to October 18, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
Quick Contact:
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