San Francisco, California
London, United Kingdom
FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official
Location: San Francisco
Dates: 8-9 Dec 2016
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s 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 Radio-logical 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 FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
The professional healthcare provider and lay people rely more and more on the use of software. It 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 has outpaced the FDA’s ability to keep up with the technology. Likewise, the industry has immersed itself in the development and use of software. The FDA’s regulatory approach has become increasingly stringent in terms of what software developers mush think about and validate. As software technology and its use become more complex and interdependent, the risks associated with problem accelerates and the correction or prevention of problem becomes almost impossible with different proprietary software. Likewise, firm’s must battle hackers. The federal government is using a peculiar approach to regulating software 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 FDA’s regulatory approach uses new premarket and post-market controls to try and reign in a problem that easily runs out of control. The FBI has stated publicly that the healthcare industry and the FDA are the least prepared 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. The FBI has stated publicly that the healthcare industry and the FDA are the least prepared entities to respond to intentional software corruption. What does your cybersecurity program cover? 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 successfully. Recalls and Medical Device Reports give you away. The current regulatory approach relies not just with the FDA, but in other areas of the federal government. You need to know and follow that evolution of current technology and applicable guidance. These are the kinds of issues that will be highlighted during the seminar.
•FDA’s regulatory strategy
•Pre-market and post-market controls
•National Institute of Science and Technology
•Professional and home use
Who Will Benefit:
•Software Design Engineers
•Hospital Risk Dept.
Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
FDA regulatory strategy
Day Two (8:30 AM - 4:30 PM)
Medical Mobile Applications (mobile apps)
Professional vs. lay use / home use
Please Click here to Enroll & for more details
Call us at : 1-732-7225220
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