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Medisafe achieves ISO 13485:2016 certification




Medication engagement company Medisafe has achieved the ISO 13485:2016 certification.

The certification supports the design and development of Software as a Medical Device (SaMD) used for the diagnosis, prognosis or prediction of disease progression.

The ISO 13485:2016 certifies Medisafe’s Quality Management Systems – a key requirement for regulatory purposes as established by IMQ.

Omri Shor, Medisafe Founder and Chief Executive Officer, said:

“Achieving ISO 13485 certification further demonstrates Medisafe’s commitment to quality and continued innovation, striving to achieve the highest standards throughout the organisation and in across our platform.

“This certification is a collective achievement of the Medisafe organisation and is an important first step toward advancing the future of connected health for pharma and patients.”

ISO 13485:2016 is an internationally-recognised quality standard specifying requirements for a quality management system used by an organisation in conjunction with the design, development, production, storage, distribution, installation or servicing of a medical device.

Medisafe demonstrated the quality of its technology’s design and development, and that all medical devices are safe and meet the applicable regulatory compliance laws and customer needs.

Medisafe has been a leading medication engagement platform for the past 10 years, with more than million patients using the technology to support their treatment journey.

Using real-world evidence to guide patients’ medication behaviour, Medisafe works with pharma organisations to create more engaging patient experiences and improve treatment outcomes.

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