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.
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