SaMD Software as a Medical Device

SaMD (Software as a Medical Device) Development Company

Phone and Stethoscope

Greenfinch Technology is an internationally based company with offices in the UK, Spain, Hungary and Ireland. We are a leading provider of healthcare software development services. These are used to create medical applications which are classified as SaMDs (Software as a Medical Device) under medical device regulations.

Image of a computer and a sthethoscope

Our team of software developers has years of experience using not only the Microsoft Technology stack but many more besides. When developing an SaMD application we always use the IEC 62304 software development process. This helps when delivering software applications that must conform to ISO 13485 regulations.

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Greenfinch Technology is a software development company with over a decade of experience. While we have vasts amounts of experience in many sectors we feel that our experience in developing SaMDs speaks for itself. We have ongoing contracts with medical companies in the UK, Ireland and the US.

Recent Medical Applications Developed by Greenfinch Technology

The Daily Mood Diary

This is an SaMD mobile app used by individuals with mental health challenges.  Through an interactive and configurable set of probing questions the App paints a longitudinal picture of a patient’s mental health. .

Vastly helpful to mental health practitioners who deal with patients who are unable to recall accurately how they felt at different times since their last appointment. This longitudinal approach with the Daily Mood Diary ensures that the patient can record all fluctuations in their mental health. From this their mental health practitioner can give a much more accurate diagnosis.

The Daily Mood Diary is a level A medical app.

Daily Mood Diary Application
RCSI Cosesca Application


COSECSA is an initiative designed to help increase the number of surgeons in Africa. We have developed an SaMD app which is an electronic log-book. This SaMD app allows trainee surgeons to keep an exact record of operations they were a part of. It also records whether they were the performing surgeon or as an assisting surgeon. It has been designed to keep track of every detail to do with the surgery and has a built-in approval process to provide feedback to the student.

What is ISO 13485?

ISO 13485 is the International Organization Standardization for medical devices. This was first published in 1996 and it represents what is necessary for a complete quality management system when designing and manufacturing medical devices.

ISO 13485

What is the IEC 62034 Standard?

IEC 62034 is recognised in both the European Union and the USA as the international standard for developing medical device software. It is the benchmark that allows medical app development to comply with both these massive markets. The IEC 62304 standard describes a risk-based decision model when using previously unused software. It also describes the test process necessary to undertake so that it can be used.

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