Medisafe Enhances Pharma Digital Vision with Latest ISO Certification

ISO 13485:2016 certification sets the company as a preferred partner for Medication Engagement and Connected Health

BOSTON, Sept. 7, 2022 /PRNewswire/ -- Medisafe, the leading medication engagement company, today announced that it has achieved the ISO 13485:2016 certification which supports the design and development of Software as a Medical Device (SaMD) used for the diagnosis, prognosis, or prediction of disease progression. Achieving this new certification serves as third-party industry validation that Medisafe continues to enhance its offering in support of pharma's vision for a more integrated and digitally enhanced future.

The ISO 13485:2016 certifies Medisafe's Quality Management Systems, a key requirement for regulatory purposes as established by IMQ. As Medisafe expands its capabilities, deepens its reach within the pharma industry, and creates advanced connectivity across the healthcare ecosystem, the certification of its quality management system supports its bold vision for the future.

"Achieving ISO 13485 certification further demonstrates Medisafe's commitment to quality and continued innovation, striving to achieve the highest standards throughout the organization and in across our platform," said Omri Shor, Medisafe Founder and Chief Executive Officer. "This certification is a collective achievement of the Medisafe organization and is an important first step toward advancing the future of connected health for pharma and patients."

ISO 13485:2016 is an internationally recognized quality standard that specifies requirements for a quality management system used by an organization in conjunction with the design, development, production, storage, distribution, installation, or servicing of a medical device. To receive the certification, Medisafe demonstrated its technology's quality in both its design and development, and that all medical devices are safe and meet the applicable regulatory compliance laws and customer needs.

For the last ten years, Medisafe has been the leading medication engagement platform that empowers more than 10 million patients to seamlessly manage their treatment journey. Using real-world evidence to guide patients' medication behavior, Medisafe works with pharma organizations to create more engaging patient experiences and improve treatment outcomes. The latest certification affirms the company's commitment to reimagine medicine through powering data science and digital technologies, positioning Medisafe as a preferred partner for future collaborations.

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, ISO 27001:2013 and ISO 13485:2016 certified. www.medisafe.com.

For information, contact:
Matt Longman
[email protected]
214-620-4364

SOURCE Medisafe