DUBLIN--(BUSINESS WIRE)--The "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" conference has been added to Research and Markets' offering.
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.
Topics:
- FDA's risk-based regulatory strategy
- Cybersecurity
- Interoperability
- 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
- Manufacturing
- Complaint Dept.
- Hospital Risk Dept.
- Own label marketers
For more information about this conference visit https://www.researchandmarkets.com/research/tq2bfn/fdas_software
