At Sumondo we strive to uphold the highest quality possible for our products and within our organisation in order to provide a safe product to our users which at the same time is beneficial for their stress levels and overall health. Below we explain what certifications we have and what standards we follow to uphold the highest quality possible.

CE-mark

Sumondo has been granted a CE mark as a class I medical device under The EU’s Medical Device Directive 93/42/EEC. This CE mark signifies that Sumondo’s device has been assessed to meet high safety and performance requirements and that Sumondo conforms to the European standards for medical devices sold on the European Economic Area (EEA) market. Having a CE mark provides evidence that we at Sumondo uphold a high quality in our products.

International standards for quality

We have a quality management system in place according to ISO 13485:2016 and the Medical Device Regulations (MDR) from the European Union. ISO stands for International Organization for Standardization, which is an independent organization that creates standards that aid in the creation of products that are safe, reliable, and of good quality.

Within our quality management system we follow the international standards ISO 14971:2019 for Risk Management, IEC 62304:2015 for Software Development, and IEC 62366-1:2015 for Usability engineering. Using these standards we design and develop our app to be as safe as possible for the user, while also ensuring that the app is easy to use. All new app features and functionalities are tested and validated before they are released.

All documents that are created or updated within our quality management system are continuously being reviewed by our top management to ensure that we stay compliant to the international standards that we use for quality management.

GDPR compliance

We at Sumondo consider your privacy as a user, and security of your data of paramount importance. We therefore have an extensive privacy and data protection policy which can be read on https://sumondo.co/privacy-policy/. In our privacy and data protection policy, we are compliant to the new General Data Protection Regulations set out by the EU to protect the data and privacy of its citizens.

Orcha Certification

The ORCHA score is designed to reward developers for best practice, and highlight poor practice and non-compliance. By following best practice, apps can earn “value points,” and poor practice or non-compliance (where necessary will earn “risk points.” The score begins at a baseline of 65% and allows apps to go up or down in score depending on the answers to the questions.
Sumondo scored 87% for Baseline review for Data Score, it was assessed at 83%. We score highest on Professional Assurance Score, where it was 90% and for Usability Accessibility Score it was 87%. These certificates could be shared, if asked for, you are welcome to reach out through info@sumondo.co