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.