Development Projects

2016-ongoing

Developing QMS software tailored for companies engaged in the development of medical devices

Our quest for the ideal QMS tool to streamline the implementation and managing our Quality Management System prompted us to embark on a journey of learning and software development, customized to meet our specific needs.

Having successfully addressed our challenges, we now advocate for this software solution among other companies facing similar dilemmas. Just as we once struggled to find a satisfactory balance between functionality and affordability, we offer our recommended software as a comprehensive solution.

QMS software

2015-ongoing

Development, certification, and promotion of devices for the early detection of heart disease

Our relentless commitment to advancing devices for the early detection of heart disease is characterized by the integration of cutting-edge AI technology and various other innovations.

Notably, we have made significant strides in detecting Heart Failure in Primary Care settings. Our device has garnered considerable attention from professionals, particularly in the UK, Spain, and across Europe.

Furthermore, it boasts certification from the European Commission, attesting to its quality and reliability. Currently, we are actively pursuing prestigious grants to further expand our research initiatives and garner recognition within the medical community.

2012-2015

Advanced Interpretive Analysis for Overall Heart Health.

A Web based diagnostic service that imports, views, shares and processes different types of bio-signals procedures.

This device performs interpretive analysis characteristic of the heart’s functionality to assist physicians better understand the physiological state of the heart and identify a broader range of pathological conditions related to heart disease leading to better prognosis of patient conditions than is possible with ECG-only analysis.

The device provides an overall indication and scoring system to improve clinical level decision system to better predict a patient’s overall heart health and risk profile.
 
It is intended for use in a clinical setting for the screening of adult populations under the supervision of a licensed healthcare practitioner.
 
It is also a peer-to-peer collaboration system for medical professionals.

2014-2015

The Future of clinical level heart diagnostic medical devices

This device is a clinical-level 3-in-1 medical device for capturing 3 different types of bio-signals, electrical, acoustical, and Mechanical.

It consists of an IE60601-2-25 certified Standard 12-Lead Diagnostic ECG, plus a 4 Lead-Phonocardiograph (PCG) and a 4-lead Mechanocardiograph (MCG). The device is controled from PC based software. It functions similarly as an ECG-only device and integrates directly into the clinical environment with little or no workflow disruption.

FDA clearance obtained June, 2015.

2008-2013

Diagnostic Research Support tool

A research software for capturing various types of bio-signals. This tool can be fine tuned to focus on minute elements of bio-signals as they are recorded. For use by Cardiologists for research purposes only.

2011-2012

Evry'U app for Android, Blackberry and iPhone

A peer-to-peer chat & nearby users app that enables several profiles to be configured by one user.

2010-2013

Investigational Medical Device

3-in-1 bio-signal capture device that includes a full functioning Standard, 12-Lead Diagnostic ECG combined with a Phonocardiograph and a Mechanocardiograph (EMPCG).

Used in several Clinical Studies, the Device meets all European and American Electrical Safety requirements.

The Device is a Class 1 Investigational Device only, in accordance with both European Medical Authority and the FDA requirements for experimental devices.

Not for use to provide patient diagnosis.

2008-2009

Auscultation Investigational Medical Device

An Investigational Only Device combining a 12-Lead Standard Diagnostic ECG and a 2-port Electronic Auscultation Device (high sensitivity electronic stethoscope).
Developed for the purpose of researching and comparing various auscultation technologies and multi-sensor innovations.

2005-2007

An Experimental Device consisting of an auscultation device (high sensitivity electronic stethoscope).