• Improving lives with the first React Native app with CE mark

    React Native App, Software as a Medical Device (SaMD)


    • Launched the first React Native App with CE mark for a SaMD (software as a medical device)
    • CE certification achieved twice with no deviations or requests for change
    • An innovative solution for optimizing health system performance by reaching new patients and bringing true relief to their lives

    The challenge

    Our client set a goal to create a new product to give diabetes patients a more affordable management solution for their condition, and bring true relief to their lives. The product had to be capable of adapting and evolving fast while being able to pass all regulations requirements for software as a medical device. In order to have access to the European market, the app needed to achieve CE mark certification. Getting this certification requires conformity with all relevant EU-wide requirements, and contains a complex process where diverse stakeholders are involved.

    The process

    The Rangle team partnered with the client’s team to implement a series of changes in an MVP to bring the project to a product level. The regulatory set of documents was, for the first time, produced in an Agile way; enabling constant improvements based on feedback while keeping the project compliant with all the regulations.  
    Rangle partnered with the client's team to create the first app that determines blood glucose ranges by taking photos with the smartphone camera without the need for a blood glucose meter. As a medical device, the project required a broad set of documents to be compliant with the mark regulations and to pass the audit performed by an independent body. Achieving those high standards enabled the application to receive the CE mark.  
    To develop the solution keeping the compliance level and, at the same time, allow the project to change and improve features, we had to help the client to adapt existent processes and redesign the delivery model. Using modern technology stack and cloud-based architecture, we reduced complexity, risk and time to market. Bringing the documentation and quality verification closer to the development cycles, we were able to work with agility, embracing changes and focusing on value delivery.  
    A complex level of test automation and code review processes were needed to achieve CE certification. The testing allowed us to measure and increase quality as we developed the product. Having this level of control and verification contributed to reduce risk and strengthen stakeholders' trust. Working together in partnership, we could deliver our ultimate goal: to bring true relief to patients' lives.

    The outcome

    Rangle, in partnership with the client, created a product that helps non-insulin-dependent patients with type 2 diabetes or pre-diabetes live healthier lives in-between doctors’ visits. A guided procedure allows the patient by using test strips and his smartphone’s camera to measure blood sugar levels. Depending on the result, the app encourages the user to take some actions, like exercising or eating. The app  allows a more affordable diabetes management solution since it does not require the traditional glucose meter, but most importantly the solution brings true relief to patient lives.

    CE recertification

    In 2019, Rangle accepted the challenge to partner with our client on this project, and began outlining what is now called our Compliance by Design process. With these methods, rooted in Agile development, we achieved the CE label without a single deviation or request for change in the audit process, and broke the client's internal record for CE review — They previously encountered a two-year cycle from development to certification, and we did it in nine months.  
    At the end of 2020, we added a new feature that would trigger a recertification and relabeling process for the entire application, not just the additional feature. With our Compliance by Design methods firmly in place, the team was once again able to achieve CE certification for the app on the first attempt, with no deviations or requests for change.
    Recommendations for a successful process in achieving CE certification within Pharma & Life sciences:
    • Invest in a modern technology stack and test automation to reduce complexity, risk and time to market
    • Highly invest in automation, this will also reduce risk and time to market
    • If working in Agile, make sure to invest in involving the stakeholders in an early phase to speed up time to market