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The firm's software platform, coupled with a robust QMS, reduces barriers to entry for companies seeking to develop SaMD and connected device applications.
May 8, 2024
By: Michael Barbella
Rip Road has received ISO 13485:2016 certification for its Quality Management System (QMS). “This certification represents an important milestone for Rip Road and reflects our commitment to quality in providing best-in-class SaMD companion applications for our clients,” Rip Road President Eric Leven said. “This certification reflects our risk-based approach to design and development of software for biologic medications and medical device applications.” ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, service, and sale of software medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements. SaMD companion applications developed on the Rip Road Platform are designed to help patients easily record and track their symptoms, get insights from their data, and share data with their Providers. “Rip Road’s platform for building customized and configurable SaMD companion apps has the potential to be a market-leading solution for helping patients manage their biologics and their delivery devices,” said Jim Collins, drug device expert and president/founder of Pharmaceutical Delivery Systems. “By fostering connectivity, they enable biopharma companies to effectively develop and launch SaMD applications and cloud-based software.” Rip Road develops and manages companion applications for biologics and medication delivery devices. The New York, N.Y.-based company has developed a configurable platform for Software as a Medical Device (SaMD) companion apps tailored for biologic medications.
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