It might look like a simple feat, but it is quite the achievement in the field of Medical Devices. Sencure has obtained the ISO 13485:2016 certificate.
ISO 13485 is the international standard for Quality Management systems for Medical Devices that manufacturers, suppliers and distributors of medical devices must follow to demonstrate their compliance with legal requirements for medical devices.
As with everything related to medical equipment, this is strictly monitored. We are incredibly proud of our team who made it possible to successfully complete the audits for this certification.
The ISO 13485 certification is the next step in our plan to bring ground-breaking innovations in medical wearables to the market. The certification opens new doors and makes it easier for partners to work with us.