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FDA Presentation 07/17/07
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Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices. Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including: -Requirements for software development as outlined in IEC 62304 -Content considerations for premarket submissions -Human factors engineering as a platform for enhanced user safety -Provisions for data security and protection against unauthorized wireless access We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
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Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices. Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including: -Requirements for software development as outlined in IEC 62304 -Content considerations for premarket submissions -Human factors engineering as a platform for enhanced user safety -Provisions for data security and protection against unauthorized wireless access We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
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Covid has drastically changed the way people work. Nowadays, many individuals can work wherever and whenever they prefer. However, this shift requires a different strategy for securing your environment. By adopting the Zero Trust principles, based on the 'Never Trust, Always Verify' mindset, you can mitigate these new risks. This session will delve into the concept and provide examples of how various HCL products can fit into this framework, particularly when it comes to building a central user repository and securing your email message flow.
Ensure the security of your HCL environment by applying the Zero Trust princi...
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International Nurses' Day is 12 May. See some of our resources ranging from histories of hospitals and organisations to personal recollections and diaries.
It will be International Nurses' Day on 12 May
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Some HCL environments are not utilized to their full extent, and that is unfortunate. If only specific modules (such as Files or Activities) are used in HCL Connections, it is not perceived and experienced as the Enterprise Social Network it truly is. If Sametime is only used for internal chat, you are missing out on integrating tailor-styled web-meeting facilities into your key processes. If an HCL Notes application is not accessible via the web, fewer users will be able to find it. Kick-start your HCL environment with three business cases that are low-hanging fruit. All you need is some (re)thinking and user adoption!
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Initially, we thought we would prepare this in the theme of ten safety commandments, but soon we discovered that we had twelve points we wanted to list. So sacrificing a title that may have been more attractive in order to present a product we feel is more complete.
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In an expanding range of tech, AI, and advanced manufacturing industries, there are growing issues and concerns for assuring: - Product safety and safety-related quality - User/patient safety - Employee/contractor safety As well as the wellbeing of other stakeholders
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Insurance IoT is a social good! Because: 🔵 Expected losses can be reduced structured programs with both real-time mitigation actions to solve a specific situation, and behavioral change mechanisms to promote safer behaviors (both in personal and commercial lines) 🔵 Rate can be matched to risks better: - Smaller and more accurate pricing clusters allow a large part of profiles to receive a lower rate - Even with the ability to price the individual probability of loss (cluster of one) the insurance foundation isn’t canceled (The risk of each policy will contribute to the expected losses of the portfolio; The premiums paid by many lucky policyholders will be used to pay the claims of the few unlucky policyholders who had an accident in a period of coverage) 🔵 IoT data can be used to increase the effectiveness and efficiency of the claim process, so improving the combined ratio ceteris paribus ⏩ Large part of the policyholders will pay less (and portfolios currently difficult to insure will become more insurable) Insurance IoT (and telematics) is not about providing a discount Insurance IoT (and telematics) is about creating economic value using the data and sharing part of this value with policyholders (and agents & brokers) An integrated holistic adoption of the IoT paradigm is a game changer for your insurance business and a social good: ◾ it allows to improve the availability and affordability of insurance coverages ◾while allowing the sector to write a profitable business Below you can enjoy a selection of best practices in both personal and commercial lines - written with some of the IoT Insurance Observatory members - that have already started to obtain results from their IoT business transformation journeys
Insurers' journeys to build a mastery in the IoT usage
Insurers' journeys to build a mastery in the IoT usage
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The RSA Conference serves as a significant platform for cybersecurity experts and vendors, to explore cutting-edge innovations in the cybersecurity field. Reach out to your target audience with our RSA Conference Exhibitor List 2024!
RSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors Data
Exhibitors Data
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0183760ssssssssssssssssssssssssssss00101011 (27).pdf
Renandantas16
Here is a presentation of some of our works for the Pharmaceutical Industry. If you are a Pharma Brand Manager and are considering hiring a creative or Event Agency, look no further. We have over 17 years of experience of working with Pharma Clients and most importantly, we address the burning issue of In-Clinic Engagement between your field executive and the Doctors
Pharma Works Profile of Karan Communications
Pharma Works Profile of Karan Communications
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Insurers' journeys to build a mastery in the IoT usage
Insurers' journeys to build a mastery in the IoT usage
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RSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors Data
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Pharma Works Profile of Karan Communications
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FDA Presentation 07/17/07
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VistA Imaging
The Regulatory Environment Daniel Carozza, MD RAC 17 July 2007
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