Greenfinch invests more than €250,000 in staff and regulatory approval for medical apps
In association with Tekenable
The software as a medical device market is expected to reach $86,451.62 million in 2027 from $18,488.00 million in 2019 according to researchandmarkets.com. It is estimated to grow at a compound annual growth rate of 21.9% from 2020 to 2027.
Greenfinch Technology – part of the Tekenable Group – has invested more than €250,000 in its team and on getting regulatory approval to allow it to go to market in Ireland, Europe and the US to support development services (SaMD) for creating medical apps.
“The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold worldwide,” said James McElhinney, security, risk & compliance officer at Greenfinch (pictured). “This investment demonstrates our ability to provide software as medical devices and related services that consistently meet our clients and applicable regulatory requirements.”
A quality management system (QMS) based on the ISO 13485 standard is the internationally accepted model a medical device organisation can implement to help demonstrate compliance to many laws and regulations of the medical device industry. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European directives and regulations.
Greenfinch uses the IEC 62304 software development process which is recognised in both the European Union and the USA helping to deliver software applications conforming to ISO 13485 regulations. The certification is audited by an external notified body and also includes training, policy procedures, software applications and enhancements and because of the nature of the product, cybersecurity controls featured heavily in the process.
Greenfinch developed the Daily Mood Diary which is an SaMD app for mobile phone. It tracks a person’s mood over an extended period and used daily it can help diagnose and address mental health issues. The Daily Mood Diary addresses the challenge that many practitioners face when speaking with patients who are unable to recall accurately how they felt last week and who respond based upon their mood on that day. This longitudinal approach ensures the patient can accurately record fluctuations in their mental health and can share this with their mental health practitioner.
Greenfinch also developed COSECA for the Royal College of Surgeons (RCSI). COSECA is an initiative to help increase the number of surgeons in Africa. Greenfinch developed an electronic log-book SaMD app. This allows trainee surgeons to keep track of operations they were a part of either as a performing surgeon or as an assistant. It keeps track of all details to do with the surgery and is funded by Irish Aid.
The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. It was postponed by one year due to Covid, and became fully applicable in 2021.