|By PR Newswire||
|March 6, 2014 05:46 PM EST||
RICHARDSON, Texas, March 6, 2014 /PRNewswire/ -- "This is a wake-up call for software companies and mobile app developers who are not used to the rigors, structure, and measured pace of the life sciences compliance world. Most of them will need a helping hand to get through the process," said Ed Roach, at the recent International Conference on Software Quality (ICSQ) in Richardson, Texas. Roach is Vice President, Consulting, for global life sciences compliance consulting firm, Maetrics. Roach contrasted the environments of the life sciences vs. the software industries. He noted that in the life sciences world, new products are developed using a scientific approach including research, trials, testing, and hopefully market introduction in compliance with predicate rules. The development of mobile apps and software has largely been just the opposite. In those industries, there is the potential to rush a product online with limited testing or lack of considerations associated with compliance to any regulations.
According to Roach, "This sharp contrast in industry cultures creates significant risk issues for software and mobile app companies who seek to do business in the life sciences sphere. Developers may find themselves in the crosshairs of their clients' supplier quality/software compliance groups where it can multiply the liability software and app companies will face as a result of the medical device manufacturer being cited for using non-compliant software or apps in their devices, forcing a recall of the product line."
According to Roach, another potentially risky trend involves apps that are used as medical devices, apps for monitoring blood glucose are prime examples. "There is a potential for a company to create and market an app in the 'wild west' world of app development, and not realize they have actually created a 'medical device' subject to U.S. or European rules and regulations or worse, liable for legal action, fines and recall."
With headquarters in Indianapolis, Indiana, USA, Maetrics is a leading compliance consulting firm that supports its global client base with offices around the world. Since 1984, Maetrics has provided strategic, managed projects, and outsourced programs to medical device, pharmaceutical, biotech, nutritional, and other FDA-regulated industries.
For more information, photography, or to schedule an interview, please contact:
Samantha Bucher – 215.627.3030
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 05:00 AM EST Reads: 1,172
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 04:45 AM EST Reads: 651
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 11, 2016 04:30 AM EST Reads: 875
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Dec. 11, 2016 03:30 AM EST Reads: 1,147
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 11, 2016 03:00 AM EST Reads: 800
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
Dec. 11, 2016 02:45 AM EST Reads: 915
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Dec. 11, 2016 02:45 AM EST Reads: 1,804
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
Dec. 11, 2016 02:30 AM EST Reads: 1,063
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 02:30 AM EST Reads: 1,300
"We are a custom software development, engineering firm. We specialize in cloud applications from helping customers that have on-premise applications migrating to the cloud, to helping customers design brand new apps in the cloud. And we specialize in mobile apps," explained Peter Di Stefano, Vice President of Marketing at Impiger Technologies, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 01:45 AM EST Reads: 756
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 11, 2016 01:45 AM EST Reads: 4,056
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 11, 2016 01:30 AM EST Reads: 1,755
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 11, 2016 01:15 AM EST Reads: 1,348
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Dec. 11, 2016 12:00 AM EST Reads: 1,133
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Dec. 11, 2016 12:00 AM EST Reads: 2,403