Bob Gleason
Sales & Marketing

Rip Road Announces ISO 13485:2016 Certification

NEW YORK, NY, March 26, 2024

Rip Road, a leading provider of Software as a Medical Device (SaMD) companion applications for biologic medications and medication delivery devices, announced today that it has received certification of their Quality Management System (QMS) to the requirements of ISO 13485:2016.

Rip Road’s pharmaceutical and medical device clients build their SaMD companion applications on the highly configurable Rip Road Platform. By leveraging this proven solution, along with our QMS, clients can more quickly, easily, and cost-effectively tailor their digital solutions to elevate the patient experience on therapy and help them optimize their medication adherence. 

"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," said Eric Leven, president of Rip Road. "We are very proud of this certification as it reflects our rigorous and 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 innovative 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, renowned drug device expert and president and founder of Pharmaceutical Delivery Systems. “By fostering connectivity, they enable biopharma companies to effectively develop and launch SaMD applications and cloud-based software.”

To learn more about the Rip Road Platform visit To schedule a demo, call Bob Gleason at 617-974-0746, or email

About Rip Road
Rip Road ( develops and manages companion applications for biologics and medication delivery devices. We have pioneered a configurable platform for Software as a Medical Device (SaMD) companion apps tailored for biologic medications. We are dedicated to elevating the patient experience, optimizing adherence, and building digital ecosystems for a connected device world.