iGRO is a Software Medical Device,
localized in various languages.
Present in 16 countries
(Europe and Latin America).
WHAT IS iGRO?
iGRO is a Software Medical Device with CE marking; it is localized in various languages and is present and used in 16 countries (European and in Latin America).
iGRO is a smart and easy to use web-based tool which is used by physicians to assess the growth response in children with idiopathic growth hormone deficit (IGDH), Turner sindrome or in children who are born small due to gestational age (SGA).
iGRO is based on the KIGS Database based on a study which uses data from over 83,000 children treated with growth hormone, collected in 52 countires over a period of 25 years and has the following characteristics:
- it can be used from any computer, including laptops and tablets;
- it is compatible with various systems and browsers;
- it does not require any software installation;
- it is compliant to all European and local regulations regarding data protection;
- it guarantees maximum safety of stored data relative to patients
HOW DOES IT WORK?
iGRO is a predictive tool and aims at supporting physicians in the decision-making process relative the treatment of children suffering from growth hormone deficit and, ultimately, improve the lives of patients around the world, guaranteeing significant benefits to all players involved in the process.
iGRO gives physicians the possibility to predict and monitor the growth trend of patients and define a completely personalized therapy which is more effective and increases treatment adherence, improving results.
With the possibility to observe and monitor the treatment process and results, patients and their families feel more empowered.
Finally, the tool significantly reduces healthcare costs and and increases financial sustainability for payers.
The stand-alone Software Medical Device was developed for Pfizer in 2016 and Kelyon was responsible for managing the project in its integrity, starting from the design of the application.
Afterwards, Kelyon helped carry out the analysis and risk management for the software, which allows to identify the risks associated with the use of the app and to determine the classification of the latter, in relation to the linked risk level, in order to implement the procedures for assessing conformity to norms and regulations.
Medical devices are divided into four classes of increasing risk; iGRO is included in Class I: "less critical devices, such as those non-active and non-invasive."
After the development phase, Kelyon supported the client through the validation phase, which provides for a verification by the intended user, thus the physician, that the device complies to all medical requirements and that the underlying formulas and algorithms function properly from a medical standpoint.
Afterwards, Kelyon oversaw the CE marking phase for the device and then implemented the Master Version in English and the subsequent localization of software for adaptation to the different countries in which it was deployed. Today, iGRO is in use in 16 countries in Europe and Latin America.
Kelyon, in addition, offers post development and installation service including Cloud Hosting of recorded patient data, users support via Help Desk through phone or e-mail, Vigilance which includes a set of activities aimed at reducing the chance of recurrence of the same incidents, Maintenance and Management of the new versions of the software, when necessary, through change management processes.
All services offered by Kelyon are delivered with the utmost attention to patient data Security and Privacy, in compliance with applicable laws and regulations on data protection.