RetinAI receives ISO 13485:2016 certification
December 2019 has arrived full of good news!
RetinAI has just received the ISO 13485:2016 certification, an important recognition awarded by regulatory bodies and necessary for companies willing to develop and commercialise Medical Devices. The ISO 13485 defines the abilities and procedures an organisation needs to demonstrate to create and distribute medical devices that meet customer and regulatory requirements. Some examples of products covered by ISO standards are Software as Medical Device (SaMD), surgical tools, heart stents, Continuous Glucose Monitoring (CGM) systems ... or even hip replacements. All of them devices used in routine medical care worldwide. RetinAI Discovery®, our platform for medical image and data management in ophthalmology, is now getting ready to be commercialised to clinics as a medical device, and this certification is clearly bringing us one step closer to empower healthcare professionals with our tools.