DUBLIN–(BUSINESS WIRE)–The “FDA’s
Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home
Use” conference has been added to Research and Markets’
For decades, firms have experienced serious problems with software and
have been at a loss to make a well-informed follow up. Software problems
represent one of the most common root causes for recalls that are
associated with deaths and serious injuries beyond what should be
necessary to quantify. FDA sees firms revise software only to create
more problems rather than solve them. The infusion pump industry is a
classic example that drove FDA to implement a new rigorous paradigm for
premarket review and performance criteria evaluation.
The growth of the medical software industry outpaces how FDA’s
regulatory process is designed. How can you anticipate and defend
against the malicious remote hacking and shut down of an insulin
infusion pump? In some instances, clinicians have weighed the risk of
software failure against the benefits of using a device at all. You need
to understand and apply the current provisions that NIST has put forth
in recent reports FDA will integrate them into its regulatory oversight
of cybersecurity management.
Device software is often used in conjunction with other software-based
devices, but their interoperability was never anticipated. Can one
software program defeat the performance capability or back up safety
features of another software program? When interoperability problems
surface, which software manufacturer takes the lead to solve the problem
and deal with proprietary software issues?
These are the kinds of issues that will be highlighted during the
webinar. The issues require careful consideration even though no obvious
answer appears at hand.
- FDA’s risk-based regulatory strategy
- National Institute of Standards and Technology
- Voluntary standards and programs
- Mobile Apps
- Premarket software validation and design requirements
- Postmarket Software recalls
Who Should Attend:
- Regulatory Affairs
- Quality Assurance
- Software Design Engineers
- Complaint Dept.
- Hospital Risk Dept.
- Own label marketers
For more information about this conference visit https://www.researchandmarkets.com/research/tq2bfn/fdas_software