Innovative Solutions in Digital Medical Devices
Innovative Solutions in Digital Medical Devices
We integrate advanced connectivity with cutting-edge medical devices.
Our Digital Medical Devices Key offering
Daily Mood Diary
TEKenable’s Daily Mood Diary, a SaMD app, tracks your mood over time. Daily use aids in diagnosing and addressing mental health issues by accurately recording mood fluctuations. This longitudinal approach helps patients and practitioners overcome recall challenges, ensuring precise mental health tracking and support.
RCSI COSECSA
COSECSA aims to increase the number of surgeons in Africa. We integrated an electronic log-book SaMD app that allows trainee surgeons to track operations they participated in as either the performing surgeon or an assistant, recording all surgical details. Since 2007, RCSI and COSECSA, funded by Irish Aid, have collaborated to train more surgeons and improve surgical care quality in sub-Saharan Africa.
What is ISO 13485?
ISO 13485, established in 1996, is the International Organisation for Standardisation’s benchmark for medical devices. It outlines the requirements for a comprehensive quality management system, essential for the design and manufacturing of medical devices.
What is IEC 62034?
IEC 62304 is the internationally recognised standard for developing medical device software, accepted in both the European Union and the USA. It serves as the benchmark ensuring medical app development complies with the regulations of these major markets.
Daily Mood Diary
Main Features
- Dynamic questions that are designed to tease out and record a patient’s mood
- Configurable Questions
- Information sent to the patient’s mental health practitioner
- Information anonymised, aggregated and stored for longitudinal studies
- Conforms to ISO 13485 and IEC 62304 standards
RCSI COSECSA
Main Features
- Digitised a paper-based system
- Optimised for tablet
- Easy to use
- Securely stores information
- Dashboard and reporting system
We deliver to ISO 13485 and IEC 62304 standards
