At Hedia, we strive to improve the lives of people with diabetes on a daily basis
That’s why we place great importance on Quality Management to guarantee the highest level of safety and security for our users. Find a list of our certifications and protocols below.
CE marking
CE stands for Conformité Européenne or European Conformity in English. Being issued the CE marking means Hedia Diabetes Assistant (HDA) meets the standards required by the European Economic Area.
HDA has been granted this CE status as a Class IIb medical device, which allows us to place the CE marking on our product. CE marking signifies the highest quality standards and ensures that we’re always in line with the excellence that the European Union’s legislation requires.
Receiving the CE mark is proof of HDA’s harmony with the EU’s Medical Device Directive 93/42/EEC which sets out the essential requirements of safety, performance, and quality.
Accordingly, Hedia Diabetes Assistant can be legally marketed and sold throughout the EU and EEA to its over 500 million consumers.
ISO 13485:2016
The International Organization for Standardization (ISO) is a globally recognised independent body that certifies international standardisation, and holds consultative status with the United Nations Economic and Social Council.
The ISO certification process for Hedia APS was conducted by TÜV SÜD. that has been undertaking inspections since 1906. TÜV SÜD is an international inspection and product certification service with locations based in about 50 countries.
Receiving the ISO 13485:2016 certification demonstrates Hedia’s ability to provide a medical device and related services that consistently meet customer and applicable regulatory requirements. The certification confirms that Hedia is able to meet the international requirements of ISO.
Cybersecurity
The threat to medical device systems from hackers and other malicious actors is becoming ever more acute.
Hedia uses a threat-modelling approach to systematically identify and address potential security vulnerabilities.
We utilise ISO 81001-5-1, ISO 14971, and MDCG 2019-16 in order to best possibly manage security for the product, and in the organisation.
User testing
When designing and developing new larger features and functionalities, Hedia conducts user testing in accordance with the IEC 62366-1 – usability standard.
Content review process
The content of Hedia Diabetes Assistant is continuously reviewed by Hedia’s medical team to ensure that all functionalities comply with current standards and diabetes care.
Specific clinical content (e.g. bolus calculator) is tested continuously to ensure product safety.
App design standards
When designing Hedia Diabetes Assistant– a Class IIb medical device – our main priority is the safety of our users.
We take a risk-based approach to new features and functionalities by following the ISO 14971 Risk Management, IEC 62304 Software Development, and IEC 82304 Product Safety Requirements standards.
Our app design is based on the core principles of Apple Human Interface Guidelines and Google Material Design Guidelines.
General Data Protection Regulation (GDPR)
At Hedia, we’re committed to the safety and security of our user’s data. We’re committed to the principles inherent in the GDPR and particularly to the concepts of privacy by design, the right to be forgotten, user consent, and a risk-based approach. In addition, we aim to ensure:
- Transparency with regard to the use of data
- That any processing is lawful, fair, transparent and necessary for a specific purpose
- That data is accurate, kept up to date and removed when no longer necessary
- That data is kept safely and securely
