James McElhinney, Security, risk and compliance officer at Greenfinch.

Greenfinch makes strategic investment to capture a slice of the $86bn global medical device SaaS market.

Dublin software company Greenfinch has invested more than €250000 in its team and medical device regulations to support software development services for the creation of apps for medical devices.

The software as a medical device market (SaMD) is estimated to grow at almost 22pc a year over the next six years, growing from $18bn in 2019 to $86bn in 2027, according to Research and Markets.com.

The medical device industry is one of the most highly regulated verticals worldwide.

James McElhinney, Security, risk and compliance officer.

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.

Last year tech services player TEKenable acquired Greenfinch Technology in a move that will create a combined business with more than 100 employees.

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.

Med in Ireland

A good example of what is possible is the Daily Mood Diary developed by Greenfinch 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 logbook 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 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,” explained James McElhinney, Security, risk and compliance officer at Greenfinch.

“This investment demonstrates our ability to provide software as medical devices and related services that consistently meet our clients and applicable regulatory requirements.”

Linked Article

Greenfinch Software as a Medical Device (SaMD) page

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