[June 30, 2016] |
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FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official - Boston, MA - 25th, 26th of August 2016 - Research and Markets
Research and Markets has announced the addition of the "FDA's
Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar
by Ex-FDA Official" conference to their offering.
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 industr 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.
Learning Objective:
- FDA's regulatory strategy
- Pre-market and post-market controls
- Interoperability
- Voluntary standards
- National Institute of Science and Technology
- Mobile Apps
- Professional and home use
- Software recalls
For more information visit http://www.researchandmarkets.com/research/tv653n/fdas_medical
View source version on businesswire.com: http://www.businesswire.com/news/home/20160630005480/en/
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