A San-Francisco based and internationally operating App Developer, Big Health, reached out to Rook Quality Systems in 2020 to discuss assistance with their software development processes in order to satisfy ISO and regulatory requirements for commercializing their software as a medical device in the United States, United Kingdom, and the EU.
Big Health’s products are innovative mobile and web applications, which provide cognitive based therapy (CBT) to aid users with sleep and anxiety. Users connect to the application in order to watch instructional videos, practice new therapeutic techniques, and log their progress. The application provides a customized therapy plan that is based upon the user’s responses to clinically tested CBT questionnaires.
Big Health has an in-house development team that utilizes the Agile methodology for developing software. At the time they reached out to Rook, they had one application that was mostly developed but lacking in documentation. Big Health sought to correct the gaps in their design documentation, verify compliance with applicable regulations and standards, and pursue formal certification under ISO13485:2016 and EU CE Marking in order to bring their product to their planned markets.
Scope of Work
Big Health requested that RookQS develop and implement their quality management systems, perform a gap analysis of their current design documentation, and lead their effort towards regulatory compliance and ISO13485:2016 certification. Big Health knew their existing software development documentation was lacking. This was primarily due to resources being dedicated to the software development, and not to the documentation of the development – a situation RookQS knows is common among emerging med device companies.
RookQS provided hands-on training on (1) QMS Requirements for Medical Devices and (2) Software Development Workflow for QMS Compliance. These training programs ensured that Big Health was aware of both overall QMS requirements, as well as how to implement those requirements into their already established development process. These training programs were developed by RookQS and based upon the requirements in 21 CFR Part 820, ISO13485:2016, IEC62304, and ISO14971.
RookQS then implemented Big Health’s QMS using Greenlight Guru, an eQMS solution. This allowed RookQS to (1) monitor and drive the maintenance of the QMS, (2) compile appropriate design records in an easy-to-audit manner, and (3) allow seamless coordination between RookQS and the client for QMS activities. RookQS prepared the QMS-software validation report for Greenlight Guru to the client, alleviating a familiar burden across the medical device industry.
RookQS also joined the design meetings and observed several sprints. Feedback was provided to Big Health in order to close the gaps between the already established development process and the regulations and standards (e.g., test cases not being linked to software design requirements; design release records not being finalized; the challenges of ensuring all potential change impacts are addressed; maintaining proper risk management practices).
Big Health’s software development team followed RookQS’ recommendations, and was able to establish compliant Design History Files for their products, improve their software development process to meet regulatory compliance, develop a robust internal Quality Management department, and effectively bring their product to market. RookQS has transitioned to a support role, assisting Big Health’s own Quality Management department by attending design reviews and providing input on proposed design changes, processing design documentation, and assisting with the continuous improvement processes (corrective and preventive actions, nonconformances, and audits).
Big Health brought their products to market in the U.S. under the COVID-19 based Emergency Use Authorization (EUA) for low-risk Cognitive Based Therapy (CBT) apps. The client was able to obtain ISO13485:2016 certification, and recently completed their initial audit for EU CE Marking. RookQS provided on-site support to Big Health for their most recent ISO13485:2016 surveillance audit, and for their initial EU Medical Device Regulations audit.
Big Health is expected to receive the CE Mark for their products by the end of Q2-2022. RookQS has also prepared a transition plan for Big Health in the event that the EUA for their products expires, and a formal FDA clearance is necessary.
RookQS can do more than create custom QMS templates; our team of engineers is also well equipped to analyze and update the QMS that your company may have already started working under. A quick gap assessment allows our team to assess your current status and identify actions that RookQS can take to align your quality documentation with your company’s business goals. No matter the stage of your QMS, RookQS has seen it all and done it all, and is ready, willing and able to assist.