|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
Providing secure, mobile access to sensitive data sets is a critical element in realizing the full potential of cloud computing. However, large data caches remain inaccessible to edge devices for reasons of security, size, format or limited viewing capabilities. Medical imaging, computer aided design and seismic interpretation are just a few examples of industries facing this challenge. Rather than fighting for incremental gains by pulling these datasets to edge devices, we need to embrace the i...
Jan. 17, 2017 05:15 PM EST Reads: 3,546
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
Jan. 17, 2017 05:00 PM EST Reads: 357
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Jan. 17, 2017 04:45 PM EST Reads: 3,034
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 17, 2017 04:45 PM EST Reads: 583
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 17, 2017 04:45 PM EST Reads: 795
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Jan. 17, 2017 04:30 PM EST Reads: 9,569
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walked through how Octob...
Jan. 17, 2017 04:30 PM EST Reads: 2,890
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Jan. 17, 2017 04:15 PM EST Reads: 1,963
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 17, 2017 03:30 PM EST Reads: 5,312
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Jan. 17, 2017 02:45 PM EST Reads: 4,099
SYS-CON Events announced today that Catchpoint, a leading digital experience intelligence company, has been named “Silver Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Catchpoint Systems is a leading Digital Performance Analytics company that provides unparalleled insight into your customer-critical services to help you consistently deliver an amazing customer experience. Designed for digital business, C...
Jan. 17, 2017 02:30 PM EST Reads: 1,732
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 17, 2017 02:15 PM EST Reads: 3,625
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Jan. 17, 2017 02:15 PM EST Reads: 3,350
"We formed Formation several years ago to really address the need for bring complete modernization and software-defined storage to the more classic private cloud marketplace," stated Mark Lewis, Chairman and CEO of Formation Data Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 17, 2017 02:15 PM EST Reads: 6,316
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
Jan. 17, 2017 02:00 PM EST Reads: 1,072