New ISO 13485:2016 certification demonstrates a commitment to delivering on clients’ quality and regulatory requirements
Chicago, IL., March 26, 2019 - Rightpoint, the independent customer experience agency with technology at its core, today announced enhancements to its established healthcare practice. The enhancements provide even greater strategic and service value to the dozens of leading healthcare providers, device manufacturers and pharmaceutical brands that entrust the agency to help them define and drive their customer experience success.
In conjunction with the enhanced practice launch, Rightpoint also announced that its new Quality Management System (QMS) has been certified by NQA US to meet the requirements of ISO 13485:2016 standard for the design and development of medical software. The certification is an internationally recognized quality standard, enabling Rightpoint to deliver FDA-approved medical grade software that meets or exceeds clients’ regulatory requirements, greatly reducing time and resources spent in the development cycle. It will benefit clients by allowing Rightpoint to take concepts for medical software through to completed and working products.
“The ability our QMS gives us to innovate products that improve lives and accelerate our clients time to market is core to our mission,” said Greg Raiz, Chief Innovation Officer at Rightpoint. “The certification also underscores Rightpoint’s long-term commitment to ethics and building software-based medical devices in a process that meets international standards for safety and quality.”
Rightpoint’s client base spans hospitals, clinical service and other care providers, insurance companies, medical device manufacturers and pharmaceutical brands. For over a decade, Rightpoint has been helping these brands, which include Abbott Laboratories, Generation One, M Health, Nima, Quell and Sanofi to transform their businesses to meet consumers’ rapidly changing expectations. From helping hospitals improve the patient experience, to designing mobile apps geared toward helping gluten-intolerant users, to building Amazon Alexa voice-based applications, Rightpoint’s breadth and scope of work have set it apart.
“Until now, we were heads down executing all of the work our healthcare clients needed to thrive throughout the earlier phases of digital transformation,” Raiz added. “At this stage, with dozens of case studies, repeatable strategies and processes defined, it is time for us to formally structure a practice that will accelerate our ability to provide our clients with tools, solutions and people who can make a difference. While the healthcare industry-at-large continues to face unprecedented disruption, we are confident that our clients are ahead of the challenges facing late adopters.