Medisafe Expands Business Solutions with New Software as a Medical Device (SaMD)

Medisafe achieves major milestone with appropriate registrations, anticipating the dynamic needs of the healthcare industry

BOSTONJan. 4, 2023 — Medisafe, a leading digital therapeutics company specializing in medication engagement, is pleased to announce its Software as a Medical Device (SaMD) technology. This announcement comes just months after achieving ISO 13485:2016 certification, meeting quality management system parameters specific to medical devices, as well as ISO 27001:2013 certification, meeting IT security management system standards specific to medication and digital health platforms. International registrations mark Medisafe’s continued leadership in the clinical management and patient engagement space.


As the number of software for the management of disease continues to grow, Medisafe’s progression represents both the company’s commitment to adhering to regulatory standards and exceeding industry expectations, as well as its leadership in the growth of SaMD.

“We’re incredibly proud of our accomplishments over the past year to better serve patients, clinicians, as well as pharma partners,” said Omri Shor, co-founder and CEO of Medisafe. “This most recent announcement of registering as a SaMD is not only a critical step in our company’s growth, it is also imperative as leaders and innovators in digital therapeutics that we anticipate and solve for evolving customer and industry, regulated and non-regulated, needs.”

In addition to these milestones, Medisafe is also continuing to focus on the non-regulated side of its business building solutions that exceed the dynamic needs of pharma, HUBs, providers, and patients—including the recent addition of its Salesforce CRM integration and Digital Document Exchange in 2022. Medisafe’s end-to-end Care Connector platform supports pharma’s vision for a more digitally-enhanced future through an interoperable, personalized, and patient-centric approach to digital patient connectivity that allows organizations to efficiently engage with patients throughout their medication journey. The value that Medisafe’s platform and digital drug companion bring to patients is validated by the more than 10 million registrants who use and rely on the technology to manage their medications.

Medisafe will be on site for the 41st Annual J.P. Morgan Healthcare Conference in San Francisco. To learn more about Medisafe’s recent advancements and how we are supporting millions of patients manage their medications, stay engaged in their therapy, and create a virtual support system toward living healthier lives, visit

About Medisafe

Medisafe is the leading medication engagement platform that empowers patients to seamlessly manage their treatment journey. By combining advanced technology and behavior science, Medisafe reimagines the treatment journey to guide patients’ specific journey needs and drive daily engagement. Its machine learning technology fuels the holistic patient engagement platform to personalize their support needs in a scalable fashion. By integrating existing patient support programs into its platform to extend capabilities, Medisafe is building a seamless future model of patient support and better health. Over 10M registered patients and caregivers rely on Medisafe’s platform, delivering double digit results toward improving outcomes. The company manages over two billion medication doses via iOS and Android smartphones and tablets. With an average rating of 4.7 out of 5 stars and more than 400,000 user reviews, Medisafe helps to create more daily engagement than Facebook or Twitter applications. Medisafe is a HIPAA and GDPR compliant solution and Medisafe is ISO 27001:2013 and ISO 13485:2016 certified


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